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Strong base
EUDAMEDFDA UDIClass I (EU MDR)
Ref 89508-1MModel Seating
by R82 A/S
Identity
- Trade Name
- Strong base EUDAMEDR82 FDA UDI
- Generic Name
- Assistive ergonomic chair, manually-adjusted FDA UDI
- Model / Reference
- Seating EUDAMED89508-1M EUDAMEDStrong Base ONE-SIZE FDA UDI
Identifiers
- Catalog Number
- 89508-1M FDA UDI
- Primary DI / UDI-DI
- 05707292540072 EUDAMEDFDA UDI
- Basic UDI-DI
- 570729212221828 EUDAMED
- FDA Product Code
- INN FDA UDI
- EMDN Code
- Y180999 CHAIRS / POSTURE SYSTEMS / SEAT POSITIONING AIDS - OTHER EUDAMED
- GMDN Term
- Assistive ergonomic chair, manually-adjusted FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3100 FDA UDI
- Market of Registration
- Denmark 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
Strong base by R82 A/S — 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 | 570729212221828 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- R82 A/S
- EUDAMED SRN
- DK-MF-000000772
Sources (2)
- EUDAMED df57efd3-b06e-4a94-becf-215f808a95f3 61 fields · synced Jul 21, 2026
- FDA UDI 4652ad30-bed4-4a3c-8420-c3a72540aa44 33 fields · synced May 30, 2026