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VALUE support arm, 850 mm, with support leg (755-905 mm), white with grey end c…
EUDAMEDFDA UDIClass I (EU MDR)
Ref R1111000Model R10, R11Ref R1111000-29
Identity
- Trade Name
- VALUE support arm, 850 mm, with support leg (755-905 mm), white with grey end cap. Height adjustable, wall-mounted EUDAMEDVALUE FDA UDI
- Generic Name
- Toilet hand rail FDA UDI
- Device Name
- Arm support VALUE EUDAMEDVALUE support arm, 850 mm, white. Height adjustable, with leg FDA UDI
- Model / Reference
- R10, R11 EUDAMEDR1111000 EUDAMEDR1111000-29 EUDAMEDR1111 FDA UDI
- Description
- VALUE support arm, 850 mm, white. Height adjustable, with leg FDA UDI
Identifiers
- Catalog Number
- R1111000 FDA UDI
- Primary DI / UDI-DI
- 57085901764372 EUDAMED57085902132934 EUDAMED05708590176437 FDA UDI
- Basic UDI-DI
- 570859035585R10WB EUDAMED
- Direct Marketing DI
- 57085901764372 EUDAMED57085902132934 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
VALUE support arm, 850 mm, with support leg (755-905 mm), white with grey end c… 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 | 570859035585R10WB | 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 (3)
- EUDAMED f46877ef-87dd-404a-b092-3c1134b8e0bc 61 fields · synced Jul 23, 2026
- EUDAMED f8c55cf8-ee59-40c6-b92c-b00c3c476a76 61 fields · synced May 19, 2026
- FDA UDI 14d1e461-9f8b-4fe5-a9a0-0f1b6316ced3 35 fields · synced May 29, 2026