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NanoCam 4K System without LED Headlight
EUDAMEDClass I (EU MDR)
Ref 4003-3004-0000
Identity
- Trade Name
- NanoCam 4K System without LED Headlight EUDAMED
- Device Name
- NanoCam 4K System without LED Headlight EUDAMED
- Model / Reference
- 4003-3004-0000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810070572471 EUDAMED
- Basic UDI-DI
- 081007057LED89UF EUDAMED
- EMDN Code
- Z129004 LIGHT SOURCES 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
NanoCam 4K System without LED Headlight by Designs for Vision, Inc. — 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 | 081007057LED89UF | Class I | Active |
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Manufacturer
- Manufacturer
- Designs for Vision, Inc.
- EUDAMED SRN
- US-MF-000013810
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED cd26002c-c473-4947-baa1-700ec509e4a2 61 fields · synced Jul 10, 2026