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Amorphous Hydrogel Dressings
EUDAMEDClass IIa (EU MDR)
Ref Tubular:5g/tube; Tubular:15g/tube; Tubular:25g/tube
Identity
- Trade Name
- Amorphous Hydrogel Dressings EUDAMED
- Device Name
- Amorphous Hydrogel Dressings EUDAMED
- Model / Reference
- Tubular:5g/tube; Tubular:15g/tube; Tubular:25g/tube EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-10AHDKL EUDAMED
- Basic UDI-DI
- B-10AHDKL EUDAMED
- EMDN Code
- M04040501 HYDROGEL DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Amorphous Hydrogel Dressings by Guangdong TiDaKang Medical Technology Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-10AHDKL | Class IIa | Active |
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Manufacturer
- Manufacturer
- Guangdong TiDaKang Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000025927
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED 9c96e9ca-142f-4c53-bfae-049fb88ef93e 61 fields · synced Jun 18, 2026
- EUDAMED 9c96e9ca-142f-4c53-bfae-049fb88ef93e-1 61 fields · synced Jun 10, 2026