Identity
- Trade Name
- ALPHANOVOCAM EUDAMEDGimmi FDA UDI
- Generic Name
- Endoscope video camera FDA UDI
- Device Name
- Camera and TV adapter EUDAMEDALPHANOVOCAM 4K UHD USB CAMERA SYSTEM INCL. CAMERA HEAD 4K 2160P FDA UDI
- Model / Reference
- S.2004.00 USB EUDAMEDFDA UDI
- Description
- ALPHANOVOCAM 4K UHD USB CAMERA SYSTEM INCL. CAMERA HEAD 4K 2160P FDA UDI
Identifiers
- Catalog Number
- S.2004.00 USB FDA UDI
- Primary DI / UDI-DI
- 04049047669692 EUDAMEDFDA UDI
- Basic UDI-DI
- 4049047ZAE13ACA27CWEQ4 EUDAMED
- Direct Marketing DI
- 04049047669692 EUDAMED
- FDA Product Code
- FWF FDA UDI
- EMDN Code
- Z12020405 SURGICAL CAMERAS EUDAMED
- GMDN Term
- Endoscope video camera FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4160 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Hydrogen Peroxide FDA UDI
Category: Endoscope video camera
Gimmi by Gimmi GmbH — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Gimmi GmbH
Sources (2)
- FDA UDI 25b0eee3-64d8-48aa-93ea-d7f42e45ff64 35 fields · synced Jul 30, 2026
- EUDAMED 41f089ec-61a6-4be7-9721-2c47dd0debec 61 fields · synced Jul 30, 2026