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Disposable Wound Protectors
EUDAMEDClass IIa (EU MDR)
Ref 115Y.102Model Model B, Model DRef 115Y.110Ref 115Y.221Ref 115Y.104Ref 115Y.133Ref 115Y.202Ref 115Y.208Ref 115Y.131Ref 115Y.108
Identity
- Trade Name
- Disposable Wound Protectors EUDAMED
- Device Name
- Disposable Wound Protectors EUDAMED
- Model / Reference
- Model B, Model D EUDAMED115Y.102 EUDAMED115Y.110 EUDAMED115Y.221 EUDAMED115Y.104 EUDAMED115Y.133 EUDAMED115Y.202 EUDAMED115Y.208 EUDAMED115Y.131 EUDAMED115Y.108 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950465511242 EUDAMED06950465511334 EUDAMED06950465514977 EUDAMED06950465511266 EUDAMED06950465514939 EUDAMED06950465514946 EUDAMED06950465514953 EUDAMED06950465514922 EUDAMED06950465511280 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 (9)
- EUDAMED 1421a9ea-8b07-451e-9c81-e122ec921f33 61 fields · synced Oct 6, 2026
- EUDAMED c60e0c1d-44ed-4c7b-8d49-bd438f8fd8f4 61 fields · synced May 16, 2026
- EUDAMED 643a0465-ecec-43ff-aa87-17f588e79996 61 fields · synced May 17, 2026
- EUDAMED df14903c-38d6-416b-b3a5-d7216fbffa49 61 fields · synced May 18, 2026
- EUDAMED 76b89979-96b2-42ff-8b38-31d4c64464db 61 fields · synced May 18, 2026
- EUDAMED 3bda53c0-a2f7-41c0-82d3-7cb32c2a91e6 61 fields · synced May 18, 2026
- EUDAMED d55efa77-c6be-42ab-bfcf-92f64c4670a7 61 fields · synced May 18, 2026
- EUDAMED c0c7f33a-aa2c-49e8-ae81-cec11499572b 61 fields · synced May 19, 2026
- EUDAMED b0e505a9-3585-4265-a5ed-5835c3fb0136 61 fields · synced May 19, 2026