Identity
- Trade Name
- Gimmi FDA UDI
- Generic Name
- Fibreoptic light cable FDA UDI
- Device Name
- AlphaSMART Light Source EUDAMEDFiber optic light cable, NIR 4.8 mm 300 cm FDA UDI
- Model / Reference
- LIG.4148.30 EUDAMEDFDA UDI
- Description
- Fiber optic light cable, NIR 4.8 mm 300 cm FDA UDI
Identifiers
- Catalog Number
- LIG.4148.30 FDA UDI
- Primary DI / UDI-DI
- 04049047787815 EUDAMEDFDA UDI
- Basic UDI-DI
- 4049047ZAD23ALA27DREUH EUDAMED
- Direct Marketing DI
- 04049047787815 EUDAMED
- FDA Product Code
- EQH FDA UDI
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMED
- GMDN Term
- Fibreoptic light cable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.4350 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
Moist Heat or Steam Sterilization FDA UDI
Category: Fibreoptic light cable
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 efb42e50-7eda-474e-8705-c7aa9136ea2a 35 fields · synced Jun 18, 2026
- EUDAMED 2fccd767-c3fa-41c2-a5e3-545399af1745 61 fields · synced Jun 18, 2026