Identity
- Trade Name
- AlphaSMART EUDAMEDGimmi FDA UDI
- Generic Name
- Endoscope video camera FDA UDI
- Device Name
- AlphaSMART Camera & Accessories EUDAMEDAlphaSMART Camera Head 4K NIR FDA UDI
- Model / Reference
- CAM.4143.00 EUDAMEDFDA UDI
- Description
- AlphaSMART Camera Head 4K NIR FDA UDI
Identifiers
- Catalog Number
- CAM.4143.00 FDA UDI
- Primary DI / UDI-DI
- 04049047788546 EUDAMEDFDA UDI
- Basic UDI-DI
- 4049047ZAE23ASA27DREZ7 EUDAMED
- Direct Marketing DI
- 04049047788546 EUDAMED
- 510(k) Number
- K221591 FDA UDI
- FDA Product Code
- FET FDA UDI
- EMDN Code
- Z12020405 SURGICAL CAMERAS EUDAMED
- GMDN Term
- Endoscope video camera FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Endoscope video camera
Gimmi by Gimmi GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K221591 also covers:
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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Gimmi GmbH
Sources (2)
- FDA UDI cfe3dadd-c086-4e20-8fbd-6b4d36ce83f2 36 fields · synced Jul 19, 2026
- EUDAMED dbd1ca23-18da-4c6c-9255-eb723fad1830 61 fields · synced Jul 19, 2026