ColdZyme
by Enzymatica AB EUDAMED 3 variants
Active
Ref 101101, 101004, 101002, 101115
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number73400311CZMSJE | Date25 Jun 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Certificates
- EPT 0477.MDR.24/5405 Active
Technical documentation EU MDR
- Notified body
- Eurofins Product Testing Italy S.r.l. 0477
- Issued
- 7 Mar 2024
- Expires
- 6 Mar 2029
- EPT 0477.MDR.24/5406 Active
Quality management system EU MDR
- Notified body
- Eurofins Product Testing Italy S.r.l. 0477
- Issued
- 7 Mar 2024
- Expires
- 6 Mar 2029
Specification
- Model / Reference
- 101101, 101004, 101002, 101115
- Primary DI / UDI-DI
- 07340031106016, 07340031105040, 07340031105019, 07340031106009
- Basic UDI-DI
- 73400311CZMSJE
- EMDN Code
- Q0399, V9017
- Device Class
- Class III
- Market of Registration
- IrelandSweden
Manufacturer details
- EUDAMED SRN
- SE-MF-000002254
Other devices from Enzymatica AB
Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No