Medela
by Zhejiang Longterm Medical Technology Co., Ltd. 13 variants
Ref 101046677Model 71mm*71mm
Active
CE MDR CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberB-06926365589520 06926365589520 | Date21 Jan 2025 | StatusActive |
| European Union | CE/MDD | NumberB-06926365589520 06926365589520 | Date21 Jan 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR, CE/MDD Active
Specification
- Device Name
- hydrogel dressing
- Model / Reference
- 71mm*71mm, 101046677
- Primary DI / UDI-DI
- 06926365589520
- Basic UDI-DI
- B-06926365589520, 692636552000682
- Direct Marketing DI
- 06926365589520
- EMDN Code
- M04040501 Hydrogel dressings, non-combined
- Device Class
- Class IIb
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000001161
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Zhejiang Longterm Medical Technology Co., Ltd.
See all devices from Zhejiang Longterm Medical Technology Co., Ltd. →
Properties
Other properties (12)
- 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