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Disposable Wound Protectors
EUDAMEDClass IIa (EU MDR)
Ref 115Y.211Model Model B, Model D
Identity
- Trade Name
- Disposable Wound Protectors EUDAMED
- Device Name
- Disposable Wound Protectors EUDAMED
- Model / Reference
- Model B, Model D EUDAMED115Y.211 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950465511372 EUDAMED
- Basic UDI-DI
- 69504655115YK7 EUDAMED
- EMDN Code
- K01020106 MINIMALLY INVASIVE SURGERY SPREADERS AND RETRACTORS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Disposable Wound Protectors by Hangzhou Kangji Medical Instrument Co. Ltd — Class IIa — 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 | 69504655115YK7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hangzhou Kangji Medical Instrument Co. Ltd
- EUDAMED SRN
- CN-MF-000008708
- Authorised Representative
- Llins Service & Consulting GmbH DE-AR-000009077
Sources (1)
- EUDAMED 90df977d-47a8-4b12-b2a8-27a2f04bd893 61 fields · synced Jun 18, 2026