Identity
- Trade Name
- Uni EUDAMEDEtac Supply Center AB FDA UDI
- Generic Name
- Assistive gripping/twisting tool, reusable FDA UDI
- Device Name
- Turner FDA UDI
- Model / Reference
- ADL EUDAMED80503003 EUDAMEDUni FDA UDI
- Description
- Turner FDA UDI
Identifiers
- Catalog Number
- 80503003 FDA UDI
- Primary DI / UDI-DI
- 07320450002397 EUDAMEDFDA UDI
- Basic UDI-DI
- 73204510364J EUDAMED
- FDA Product Code
- IKW FDA UDI
- EMDN Code
- Y0999 PERSONAL CARE AIDS - OTHER EUDAMED
- GMDN Term
- Assistive gripping/twisting tool, reusable 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
Uni 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 | 73204510364J | 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 (2)
- EUDAMED 44637a85-acf1-4c4e-b8ae-e82902f4bb5c 61 fields · synced Jun 18, 2026
- FDA UDI ddf61b7d-60b7-46f6-91f9-e68b0cd36c29 34 fields · synced May 30, 2026