Sterilization Pouches and Reels
by Shanghai Jianzhong Medical Packaging Co., Ltd EUDAMED
Active
Ref 1211Model a)Sterilization Pouches,flat,self seal ;b)Sterilization Pouches,flat,heat seal ;c)Sterilization Pouches,gusseted,self seal ;d)Sterilization Reels,flat,heat seal; e)Sterilization Reels,gusseted,heat seal
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697462348137354X | Date8 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Model / Reference
- a)Sterilization Pouches, flat, self seal, b)Sterilization Pouches, heat seal, c)Sterilization Pouches, gusseted, d)Sterilization Reels, e)Sterilization Reels, 1211
- Primary DI / UDI-DI
- 06974623480683
- Basic UDI-DI
- 697462348137354X
- EMDN Code
- S01020101 Flat sterilisation reels, paper/plastic film
- Device Class
- Class I
- Market of Registration
- Denmark
Manufacturer details
- EUDAMED SRN
- CN-MF-000013547
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
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Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No