Identity
- Trade Name
- Medela EUDAMED
- Device Name
- Hydrogel dressing EUDAMED
- Model / Reference
- 101046683 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926365589643 EUDAMED
- Basic UDI-DI
- 692636552000682 EUDAMED
- Direct Marketing DI
- 06926365589643 EUDAMED
- EMDN Code
- M04040501 HYDROGEL DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Medela by Zhejiang Longterm Medical Technology Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 692636552000682 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Zhejiang Longterm Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000001161
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 597e03c4-f74e-4478-9f3a-99c4239d0e11 61 fields · synced Jun 18, 2026