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medical endoscope camera
EUDAMEDClass I (EU MDR)
Ref HCM 8260Model HCM 8260, HCM 8261, HCM 8262, HCM 8263, HCM 8264, HCM 8265, HCM 8266, HCM 8267, HCM 8268, HCM 8269, HCM8270, HCM8271, HCM8272, HCM8273, HCM8274, HCM8275, HCM8276, HCM8277, HCM8278, HCM8279
Identity
- Device Name
- medical endoscope camera EUDAMED
- Model / Reference
- HCM 8260, HCM 8261, HCM 8262, HCM 8263, HCM 8264, HCM 8265, HCM 8266, HCM 8267, HCM 8268, HCM 8269, HCM8270, HCM8271, HCM8272, HCM8273, HCM8274, HCM8275, HCM8276, HCM8277, HCM8278, HCM8279 EUDAMEDHCM 8260 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974193970126 EUDAMED
- Basic UDI-DI
- 697419397MEC001LX EUDAMED
- EMDN Code
- Z12020405 SURGICAL CAMERAS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
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
medical endoscope camera by Nantong Healthcare Medical Instrument Co., 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 | 697419397MEC001LX | Class I | Active |
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Manufacturer
- Manufacturer
- Nantong Healthcare Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000050033
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 07c022a6-2a61-45c9-957c-1081ca7162b1 61 fields · synced Oct 6, 2026