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4K Medical Endoscopic Camera System
EUDAMEDClass I (EU MDR)
Ref wMerak 40sModel wMerak 40u, wlerak 40p, wMerak 40a, wMlerak40g, wMerak40s, wMerak 40e, wMerak40c, wMerak40b, wDubhe V40A, wDubhe V40B、wDubhe V40C、wDubhe V40D, wDubhe V40E、wDubhe V40FRef wMerak 40gRef wDubhe V40CRef wDubhe V40DRef wMerak 40pRef wDubhe V40ERef wDubhe V40FRef wMerak 40eRef wMerak 40bRef wMerak 40aRef wMerak 40uRef wDubhe V40B
Identity
- Trade Name
- 4K Medical Endoscopic Camera System EUDAMED
- Device Name
- 4K Medical Endoscopic Camera System EUDAMED
- Model / Reference
- wMerak 40u, wlerak 40p, wMerak 40a, wMlerak40g, wMerak40s, wMerak 40e, wMerak40c, wMerak40b, wDubhe V40A, wDubhe V40B、wDubhe V40C、wDubhe V40D, wDubhe V40E、wDubhe V40F EUDAMEDwMerak 40s EUDAMEDwMerak 40g EUDAMEDwDubhe V40C EUDAMEDwDubhe V40D EUDAMEDwMerak 40p EUDAMEDwDubhe V40E EUDAMEDwDubhe V40F EUDAMEDwMerak 40e EUDAMEDwMerak 40b EUDAMEDwMerak 40a EUDAMEDwMerak 40u EUDAMEDwDubhe V40B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975621670625 EUDAMED06975621670618 EUDAMED06975621670298 EUDAMED06975621670304 EUDAMED06975621670021 EUDAMED06975621670311 EUDAMED06975621670328 EUDAMED06975621670632 EUDAMED06975621670649 EUDAMED06975621670038 EUDAMED06975621670014 EUDAMED06975621670281 EUDAMED
- Basic UDI-DI
- 697562167Z120204010187 EUDAMED
- EMDN Code
- Z12020401 INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
4K Medical Endoscopic Camera System by Weyo Surgical Technology Ltd. — Class I — 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 | 697562167Z120204010187 | Class I | Active |
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Manufacturer
- Manufacturer
- Weyo Surgical Technology Ltd.
- EUDAMED SRN
- CN-MF-000038773
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (12)
- EUDAMED 5ee0e088-5b97-4f96-9eae-dc8c0340351b 61 fields · synced Aug 1, 2026
- EUDAMED af13a389-5e2f-4a2b-b3e0-4f2a5c12c415 61 fields · synced May 16, 2026
- EUDAMED c524fea8-35c4-4b8d-870c-a6964e290770 61 fields · synced May 16, 2026
- EUDAMED 748c79dc-0017-4cab-ad5c-e18579c65d1c 61 fields · synced May 16, 2026
- EUDAMED b8cedb41-3f6b-4435-8e4f-463de6b2759f 61 fields · synced May 17, 2026
- EUDAMED 0b6c766a-9c3d-4c34-9b9c-50f491276a38 61 fields · synced May 17, 2026
- EUDAMED 8bc66d7d-9fa6-4099-bdeb-819b3cfc5e52 61 fields · synced May 17, 2026
- EUDAMED c533c0e3-38db-4baf-835a-d88ede102c4e 61 fields · synced May 17, 2026
- EUDAMED c8f79415-4fb7-4c15-8943-31b54ce101a3 61 fields · synced May 18, 2026
- EUDAMED 09ec04ca-49c2-4650-b90c-f3d4051bd0d1 61 fields · synced May 18, 2026
- EUDAMED ca3289ea-d2f5-4df3-9a68-f06d268ebe19 61 fields · synced May 18, 2026
- EUDAMED d4aebcd5-f842-41d7-afab-feb347a26350 61 fields · synced May 18, 2026