Leg Bag Sleeve
by Hangzhou Primecare Medical Co., Ltd. EUDAMED
Active
Ref 05/02/13/M/GHC, 07/30/EB/XL, 05/02/12/M/GHC, 05/02/13/L/GHC, 05/03/10/L/GHC, 05/02/13/S/GHC, 05/02/13/XL/GHC, 05/02/12/L/GHC
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697236069UB05KV | Date26 Jul 2025 | 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- Withdrawn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
- 05/02/13/M/GHC, 07/30/EB/XL, 05/02/12/M/GHC, 05/02/13/L/GHC, 05/03/10/L/GHC, 05/02/13/S/GHC, 05/02/13/XL/GHC, 05/02/12/L/GHC
- Primary DI / UDI-DI
- 06972360692291, 06972360693489, 06972360692253, 06972360692307, 06972360692321, 06972360692284, 06972360694875, 06972360692260
- Basic UDI-DI
- 697236069UB05KV
- EMDN Code
- A0680 Drainage and fluid collection devices - accessories
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000011403
- Authorised representative
- MedPath GmbH DE-AR-000000087
Other devices from Hangzhou Primecare Medical Co., Ltd.
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