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Royal Double Fleece
EUDAMEDFDA UDIClass I (EU MDR)
Ref RK1P-0A-10Ref ORK1P-12-12
Identity
- Trade Name
- ROYAL DOUBLE FLEECE EUDAMEDFDA UDI
- Generic Name
- Stump sock FDA UDI
- Device Name
- Royal Flush EUDAMED(10"-14") Double Fleece 1 Ply White Medium With Hole FDA UDI
- Model / Reference
- RK1P-0A-10 EUDAMEDORK1P-12-12 EUDAMEDFDA UDI
- Description
- (10"-14") Double Fleece 1 Ply White Medium With Hole FDA UDI
Identifiers
- Catalog Number
- ORK1P-12-12 FDA UDI
- Primary DI / UDI-DI
- +G296RK1P0A100 EUDAMED+G296ORK1P12120 EUDAMEDG296ORK1P12120 FDA UDI
- Basic UDI-DI
- ++G296PROSTHEICSOCKSQD EUDAMED
- FDA Product Code
- FQL FDA UDI
- EMDN Code
- Y090327 SOCKS FOR PROSTHESES EUDAMED
- GMDN Term
- Stump sock FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5780 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
No
FDA UDI
Royal Double Fleece by Royal Knit, Inc. — 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 | ++G296PROSTHEICSOCKSQD | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Royal Knit, Inc
- EUDAMED SRN
- US-MF-000004427
- Authorised Representative
- Code of Practice AB SE-AR-000003002
Sources (3)
- EUDAMED 0a677913-6641-4408-b91b-dbb28627d07d 61 fields · synced Aug 2, 2026
- EUDAMED 0e65b4eb-d476-44ce-ab47-e99ff416484e 61 fields · synced May 18, 2026
- FDA UDI c0569d9e-e47a-4bdc-819c-40a86c351c2b 34 fields · synced May 30, 2026