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EUDAMEDFDA UDIClass I (EU MDR)
Ref 80403003Model ADLRef 80403001Ref 80402007
Identity
- Trade Name
- Light EUDAMEDEtac Supply Center AB FDA UDI
- Generic Name
- Assistive cutlery FDA UDI
- Device Name
- Dessert spoon, thick, 177 FDA UDI
- Model / Reference
- ADL EUDAMED80403003 EUDAMED80403001 EUDAMED80402007 EUDAMEDLight FDA UDI
- Description
- Dessert spoon, thick, 177 FDA UDI
Identifiers
- Catalog Number
- 80402007 FDA UDI
- Primary DI / UDI-DI
- 07320450002151 EUDAMED07320450002137 EUDAMED07320450002106 EUDAMEDFDA UDI
- Basic UDI-DI
- 73204510294M EUDAMED
- FDA Product Code
- ILC FDA UDI
- EMDN Code
- Y150912 CUTLERY EUDAMED
- GMDN Term
- Assistive cutlery FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.5050 FDA UDI
- Market of Registration
- Sweden 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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Light by Etac Supply Center Ab — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 73204510294M | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Etac Supply Center AB
- EUDAMED SRN
- SE-MF-000001230
Sources (4)
- EUDAMED b2e11999-c214-4176-a8d0-53d198e79f8d 61 fields · synced Aug 1, 2026
- EUDAMED 2b87c7a5-2507-4629-a229-65095501a633 61 fields · synced May 16, 2026
- EUDAMED 43724eed-9332-47e8-b2de-e1d3f0015f9e 61 fields · synced May 18, 2026
- FDA UDI e38aa288-984b-4587-af8a-482d3c16b2c4 34 fields · synced May 30, 2026