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Biocidal product factsheet - Last updated: 09/09/2024

Biocidal Product details

Trade name:

SPOR-KLENZ READY TO USE SPORICIDE / DISINFECTANT

Spor-Klenz Ready To Use Sporicide/Disinfectant

Spor-Klenz RTU ETO Process Packaged Cold Sterilant

Product-type:

PT02

Active Substance details

Substance name:

Peracetic acid

IUPAC name:

ethaneperoxoic acid

EC number:

201-186-8

CAS number:

79-21-0

BAS number:

1340

Authorised
map
Authorisation information

Authorisation type:

National authorisation

Legal act:

Assessment reports:

20240429_NL-0032412-0000_Final PAR (Public).pdf (en)

13 authorisations in the product cluster
Trade name
Product-type
Market area
Authorisation holder
Authorisation number
Authorisation start
Authorisation end
SPC Decisions
Authorisation status
R4BP 3 asset
National

Spor-Klenz Ready To Use Sporicide/Disinfectant

Spor-Klenz RTU ETO Process Packaged Cold Sterilant
PT02

Netherlands

 STERIS Ireland Limited NL-0032412-0001 NL-0032412-0000 08/05/2024 08/05/2034

Family SPC  (en)

Member SPC  (en)

20240429_NL-0032412-0000_Authorisation.docx (nl)

 Authorised

Spor-Klenz Ready To Use Sporicide/Disinfectant

Spor-Klenz RTU ETO Process Packaged Cold Sterilant
PT02

Austria

 STERIS Ireland Limited AT-0032419-0001 see authorisation letter 06/08/2024 08/05/2034

Family SPC  (de)

Member SPC  (de)

2024-0.575.304_Zulassungsbescheid.pdf (de)

Spor-Klenz Product Family_Anlage 1.pdf (de)

 Authorised

Spor-Klenz Ready To Use Sporicide/Disinfectant

Spor-Klenz RTU ETO Process Packaged Cold Sterilant
PT02

Belgium

 STERIS Ireland Limited BE-0032413-0001 BE2024-0015-00-00 30/05/2024 08/05/2034

Family SPC  (fr)

Member SPC  (fr)

BE2024-0015-01-01_Act(FR)_Spor-Klenz Ready to Use ETO Process Packaged Cold Sterilant.pdf (fr)

BE2024-0015-01-00_Act(FR)_Meta_1.pdf (fr)

BE2024-0015-02-01_Act(FR)_Spor-Klenz Ready To Use Sporicide Wipes.pdf (fr)

BE2024-0015-00-00_Act(FR)_Spor-Klenz Product Family.pdf (fr)

BE2024-0015-02-00_Act(FR)_Meta_2.pdf (fr)

 Authorised

Spor-Klenz Ready To Use Sporicide/Disinfectant

Spor-Klenz RTU ETO Process Packaged Cold Sterilant
PT02

Croatia

 STERIS Ireland Limited HR-0032425-0001 KLASA:UP/I-543-04/24-12/02 14/08/2024 08/05/2034

Family SPC  (hr)

Member SPC  (hr)

Spor-Klenz Product Family (HR HR)_rjesenje.pdf (hr)

 Authorised

Spor-Klenz Ready To Use Sporicide/Disinfectant

Spor-Klenz RTU ETO Process Packaged Cold Sterilant
PT02

Denmark

 STERIS Ireland Limited DK-0032415-0001 952-1 08/05/2024 08/05/2034

Family SPC  (da)

Member SPC  (da)

Godkendelsesbrev_BPR_Spor-Klenz Product Family.pdf (da)

 Authorised

Spor-Klenz Ready To Use Sporicide/Disinfectant

Spor-Klenz RTU ETO Process Packaged Cold Sterilant
PT02

Finland

 STERIS Ireland Limited FI-0032418-0001 FI-2024-0026 05/07/2024 08/05/2034

Family SPC  (fi)

Member SPC  (fi)

Spor-Klenz_Product_Family_NA-MRP_05072024.pdf (fi)

 Authorised

SPOR-KLENZ READY TO USE SPORICIDE / DISINFECTANT

SPOR-KLENZ RTU ETO PROCESS PACKAGED COLD STERILANT
PT02

France

 STERIS Ireland Limited FR-0032416-0001 FR-2024-0035 28/06/2024 08/05/2034

Family SPC  (fr)

Member SPC  (fr)

SPORKLENZP_BC-ST053069-07_NA-MRP_D.pdf (fr)

 Authorised

Spor-Klenz Ready To Use Sporicide/Disinfectant

Spor-Klenz RTU ETO Process Packaged Cold Sterilant
PT02

Germany

 STERIS Ireland Limited DE-0032414-0001 DE-0032414-00-0000-02 15/05/2024 08/05/2034

Family SPC  (de)

Member SPC  (de)

 Authorised

Spor-Klenz Ready To Use Sporicide/Disinfectant

Spor-Klenz RTU ETO Process Packaged Cold Sterilant
PT02

Italy

 STERIS Ireland Limited IT-0032423-0001 IT/2024/00956/MRP 08/05/2024 08/05/2034

Family SPC  (it)

Member SPC  (it)

- decreto NA- MRP BC-RN053073-31 SPOR-KLENZ PRODUCT FAMILY+spc.pdf (it)

 Authorised

Spor-Klenz Ready To Use Sporicide/Disinfectant
PT02

Poland

 STERIS Ireland Limited PL-0032417-0001 PL/2024/0671/MR/BPF 04/06/2024 08/05/2034

Family SPC  (pl)

Member SPC  (pl)

PL.2024.0671.MR.BPF_Spor-Klenz Product Family_D.pdf (pl)

 Authorised

Spor-Klenz RTU ETO Process Packaged Cold Sterilant
PT02

Portugal

 STERIS Ireland Limited PT-0032426-0001 PT/DGS ARM PB-56/2024;PT/DGS ARM PB-58/2024PT/DGS ARM PB-57/2024; 08/05/2024 08/05/2034

Family SPC  (pt)

Member SPC  (pt)

AV PT DGS ARM PB 58 2024.pdf (pt)

AV PTDGS ARM PB 57 2024.pdf (pt)

AV PT DGS ARM PB 56 2024.pdf (pt)

 Authorised

Spor-Klenz Ready To Use Sporicide/Disinfectant

Spor-Klenz RTU ETO Process Packaged Cold Sterilant
PT02

Spain

 STERIS Ireland Limited ES-0032421-0001 ES/MRF(NA)-2024-02-00947 10/07/2024 29/05/2034

Family SPC  (es)

Member SPC  (es)

R4BP3-ES-0032421-0000-Authorisation.pdf (es)

 Authorised

Spor-Klenz Ready To Use Sporicide/Disinfectant

Spor-Klenz RTU ETO Process Packaged Cold Sterilant
PT02

Switzerland

 STERIS Ireland Limited CH-0032420-0001 CH-2024-0008 24/06/2024 08/05/2034

Family SPC  (fr)

Member SPC  (fr)

 Authorised
Reference authorisation
Trade name: Spor-Klenz Ready To Use Sporicide/Disinfectant , Spor-Klenz RTU ETO Process Packaged Cold Sterilant
Authorisation number: NL-0032412-0001| Market area: Netherlands

1 assessment record available

Application of national authorisation

Evaluating authority:

Netherlands

Conclusion date:

29/04/2024

Validity of authorisation

Start date:

08/05/2024

End date:

08/05/2034

SPC

Family SPC  (en)

Member SPC  (en)

Mutual recognition
Trade name: Spor-Klenz Ready To Use Sporicide/Disinfectant , Spor-Klenz RTU ETO Process Packaged Cold Sterilant
Authorisation number: AT-0032419-0001| Market area: Austria

1 assessment record available

Mutual recognition in parallel

Evaluating authority:

Austria

Conclusion date:

08/08/2024

Validity of authorisation

Start date:

06/08/2024

End date:

08/05/2034

SPC

Family SPC  (de)

Member SPC  (de)

Trade name: Spor-Klenz Ready To Use Sporicide/Disinfectant , Spor-Klenz RTU ETO Process Packaged Cold Sterilant
Authorisation number: BE-0032413-0001| Market area: Belgium

1 assessment record available

Mutual recognition in parallel

Evaluating authority:

Belgium

Conclusion date:

31/05/2024

Validity of authorisation

Start date:

30/05/2024

End date:

08/05/2034

SPC

Family SPC  (fr)

Member SPC  (fr)

Trade name: Spor-Klenz Ready To Use Sporicide/Disinfectant , Spor-Klenz RTU ETO Process Packaged Cold Sterilant
Authorisation number: HR-0032425-0001| Market area: Croatia

1 assessment record available

Mutual recognition in parallel

Evaluating authority:

Croatia

Conclusion date:

14/08/2024

Validity of authorisation

Start date:

14/08/2024

End date:

08/05/2034

SPC

Family SPC  (hr)

Member SPC  (hr)

Trade name: Spor-Klenz Ready To Use Sporicide/Disinfectant , Spor-Klenz RTU ETO Process Packaged Cold Sterilant
Authorisation number: DK-0032415-0001| Market area: Denmark

2 assessment records available

Amendment of national authorisation

Evaluating authority:

Denmark

Conclusion date:

14/05/2024

Validity of authorisation

Start date:

08/05/2024

End date:

08/05/2034

SPC

Family SPC  (da)

Member SPC  (da)

Mutual recognition in parallel

Evaluating authority:

Denmark

Conclusion date:

08/05/2024

Validity of authorisation

Start date:

08/05/2024

End date:

08/05/2034

SPC

SPC not available

Trade name: Spor-Klenz Ready To Use Sporicide/Disinfectant , Spor-Klenz RTU ETO Process Packaged Cold Sterilant
Authorisation number: FI-0032418-0001| Market area: Finland

1 assessment record available

Mutual recognition in parallel

Evaluating authority:

Finland

Conclusion date:

05/07/2024

Validity of authorisation

Start date:

05/07/2024

End date:

08/05/2034

SPC

Family SPC  (fi)

Member SPC  (fi)

Trade name: SPOR-KLENZ READY TO USE SPORICIDE / DISINFECTANT , SPOR-KLENZ RTU ETO PROCESS PACKAGED COLD STERILANT
Authorisation number: FR-0032416-0001| Market area: France

1 assessment record available

Mutual recognition in parallel

Evaluating authority:

France

Conclusion date:

03/07/2024

Validity of authorisation

Start date:

28/06/2024

End date:

08/05/2034

SPC

Family SPC  (fr)

Member SPC  (fr)

Trade name: Spor-Klenz Ready To Use Sporicide/Disinfectant , Spor-Klenz RTU ETO Process Packaged Cold Sterilant
Authorisation number: DE-0032414-0001| Market area: Germany

1 assessment record available

Mutual recognition in parallel

Evaluating authority:

Germany

Conclusion date:

15/05/2024

Validity of authorisation

Start date:

15/05/2024

End date:

08/05/2034

SPC

Family SPC  (de)

Member SPC  (de)

Trade name: Spor-Klenz Ready To Use Sporicide/Disinfectant , Spor-Klenz RTU ETO Process Packaged Cold Sterilant
Authorisation number: IT-0032423-0001| Market area: Italy

1 assessment record available

Mutual recognition in parallel

Evaluating authority:

Italy

Conclusion date:

20/06/2024

Validity of authorisation

Start date:

08/05/2024

End date:

08/05/2034

SPC

Family SPC  (it)

Member SPC  (it)

Trade name: Spor-Klenz Ready To Use Sporicide/Disinfectant
Authorisation number: PL-0032417-0001| Market area: Poland

1 assessment record available

Mutual recognition in parallel

Evaluating authority:

Poland

Conclusion date:

08/07/2024

Validity of authorisation

Start date:

04/06/2024

End date:

08/05/2034

SPC

Family SPC  (pl)

Member SPC  (pl)

Trade name: Spor-Klenz RTU ETO Process Packaged Cold Sterilant
Authorisation number: PT-0032426-0001| Market area: Portugal

1 assessment record available

Mutual recognition in parallel

Evaluating authority:

Portugal

Conclusion date:

06/09/2024

Validity of authorisation

Start date:

08/05/2024

End date:

08/05/2034

SPC

Family SPC  (pt)

Member SPC  (pt)

Trade name: Spor-Klenz Ready To Use Sporicide/Disinfectant , Spor-Klenz RTU ETO Process Packaged Cold Sterilant
Authorisation number: ES-0032421-0001| Market area: Spain

1 assessment record available

Mutual recognition in parallel

Evaluating authority:

Spain

Conclusion date:

12/07/2024

Validity of authorisation

Start date:

10/07/2024

End date:

29/05/2034

SPC

Family SPC  (es)

Member SPC  (es)

Trade name: Spor-Klenz Ready To Use Sporicide/Disinfectant , Spor-Klenz RTU ETO Process Packaged Cold Sterilant
Authorisation number: CH-0032420-0001| Market area: Switzerland

1 assessment record available

Mutual recognition in parallel

Evaluating authority:

Switzerland

Conclusion date:

24/06/2024

Validity of authorisation

Start date:

24/06/2024

End date:

08/05/2034

SPC

Family SPC  (fr)

Member SPC  (fr)