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Hugemed
EUDAMEDClass I (EU MDR)
Ref 8800BModel VL3R, VL3D, VL3REX, VL3DEX, VL4R, VL4D, VL4REX, VL4DEX, VL3N, VL4N, VLRM, VLDM, VL3H, VL3S, VLMCF, VL4CT
Identity
- Trade Name
- Hugemed EUDAMED
- Device Name
- Video Laryngoscope EUDAMED
- Model / Reference
- VL3R, VL3D, VL3REX, VL3DEX, VL4R, VL4D, VL4REX, VL4DEX, VL3N, VL4N, VLRM, VLDM, VL3H, VL3S, VLMCF, VL4CT EUDAMED8800B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970462540045 EUDAMED
- Basic UDI-DI
- 69704625488009V EUDAMED
- Direct Marketing DI
- 06970462540045 EUDAMED
- EMDN Code
- Z12021004 VIDEO LARYNGOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Hugemed by Shenzhen HugeMed Medical Technical Development 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 | 69704625488009V | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000010895
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED c756ce48-e5ea-4c46-9a7f-065c84604f54 61 fields · synced May 23, 2026