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Edge
EUDAMEDFDA UDIClass I (EU MDR)
Ref 81801010-VGModel Shower SeatsRef 81801040
Identity
- Trade Name
- Edge EUDAMEDEtac Supply Center AB FDA UDI
- Generic Name
- Shower seat, non-powered FDA UDI
- Device Name
- Grey, low FDA UDI
- Model / Reference
- Shower Seats EUDAMED81801010-VG EUDAMED81801040 EUDAMEDEdge FDA UDI
- Description
- Grey, low FDA UDI
Identifiers
- Catalog Number
- 81801040 FDA UDI
- Primary DI / UDI-DI
- 07320450178467 EUDAMED07320451327123 EUDAMEDFDA UDI
- Basic UDI-DI
- 732045101142 EUDAMED
- FDA Product Code
- INN FDA UDI
- EMDN Code
- Y093303 FIXED AND ROTARY CHAIRS FOR BATH AND SHOWER EUDAMED
- GMDN Term
- Shower seat, non-powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3100 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Edge 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 | 732045101142 | 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 (3)
- EUDAMED 8fec890f-4b2e-4423-9d72-60dccebe867c 61 fields · synced Jul 14, 2026
- EUDAMED 9acd9f24-4510-4b48-9d65-c8b3515f705c 61 fields · synced May 18, 2026
- FDA UDI 2b5cf113-3085-4ef8-94e5-99ab2d5f1a4a 34 fields · synced May 30, 2026