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PLUS support arm, 850 mm, red. Height adjustable, left hand operated, for retro…
EUDAMEDFDA UDIClass I (EU MDR)
Ref R371385035Model R37
Identity
- Trade Name
- PLUS support arm, 850 mm, red. Height adjustable, left hand operated, for retro-fitting EUDAMEDPLUS FDA UDI
- Generic Name
- Toilet hand rail FDA UDI
- Device Name
- Arm support PLUS H EUDAMEDPLUS support arm, 850 mm, red. Height adjustable, left hand operated, for retro-fitting FDA UDI
- Model / Reference
- R37 EUDAMEDR371385035 EUDAMEDR371385 FDA UDI
- Description
- PLUS support arm, 850 mm, red. Height adjustable, left hand operated, for retro-fitting FDA UDI
Identifiers
- Catalog Number
- R371385035 FDA UDI
- Primary DI / UDI-DI
- 57085903683510 EUDAMED05708590368351 FDA UDI
- Basic UDI-DI
- 570859035585R37WX EUDAMED
- Direct Marketing DI
- 57085903683510 EUDAMED
- FDA Product Code
- ILS FDA UDI
- EMDN Code
- Y181809 ARMRESTS EUDAMED
- GMDN Term
- Toilet hand rail FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.5050 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
PLUS support arm, 850 mm, red. Height adjustable, left hand operated, for retro… by Pressalit A/S — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 570859035585R37WX | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Pressalit A/S
- EUDAMED SRN
- DK-MF-000001767
Sources (2)
- EUDAMED 18e33986-1ab6-460b-9e99-a1a06934ec70 61 fields · synced Aug 1, 2026
- FDA UDI 967021e4-7ee8-4d37-94fc-bd798705b0a4 35 fields · synced May 29, 2026