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wound set
EUDAMEDClass IIa (EU MDR)
Ref 990202Ref 990201Ref 990204Ref 990207Ref 990209Ref 990203
Identity
- Trade Name
- wound set EUDAMED
- Device Name
- Wound Dressing kit EUDAMEDDressing pack EUDAMED
- Model / Reference
- 990202 EUDAMED990201 EUDAMED990204 EUDAMED990207 EUDAMED990209 EUDAMED990203 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978419029681 EUDAMED06978419029667 EUDAMED06978419029742 EUDAMED06978419029827 EUDAMED06978419029889 EUDAMED06978419029728 EUDAMED
- Basic UDI-DI
- 697240330WDK000010R8 EUDAMED697240330DP00000132 EUDAMED
- EMDN Code
- V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I 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
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
wound set by Xuchang Zhende Surgical Dressing Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ophthalmic surgical procedure kit, non-medicated, single-use.
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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 | 697240330WDK000010R8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Xuchang Zhende Surgical Dressing Co., Ltd
- EUDAMED SRN
- CN-MF-000009222
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (6)
- EUDAMED 45fe0c1f-f541-4f2c-a503-082b7f2a3941 61 fields · synced Oct 6, 2026
- EUDAMED 9683eba9-b199-4599-a8b2-728112095344 61 fields · synced May 17, 2026
- EUDAMED 25d1f9b4-ec67-464a-a9cc-586284859609 61 fields · synced May 18, 2026
- EUDAMED b4946632-ad14-4189-a4d8-58503f2bd0b5 61 fields · synced May 18, 2026
- EUDAMED 10096d49-56d3-4296-ac6c-ecc9b75a109e 61 fields · synced May 18, 2026
- EUDAMED afdbaf2c-62b6-4ee0-9b0e-c84f9b750596 61 fields · synced May 19, 2026