Identity
- Trade Name
- Crocodile EUDAMEDR82 FDA UDI
- Generic Name
- Handgrip disability-assistive walker, non-powered, foldable FDA UDI
- Model / Reference
- Walking EUDAMED86802 EUDAMEDCrocodile, size 2 FDA UDI
Identifiers
- Catalog Number
- 86802 FDA UDI
- Primary DI / UDI-DI
- 05707292355959 EUDAMEDFDA UDI
- Basic UDI-DI
- 570729212060627 EUDAMED
- FDA Product Code
- ITJ FDA UDI
- EMDN Code
- Y120699 WALKING DEVICES, TWO-HANDED OPERATION - OTHER EUDAMED
- GMDN Term
- Handgrip disability-assistive walker, non-powered, foldable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3825 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
Crocodile 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 | 570729212060627 | 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 fc39054b-e21a-474f-adce-f134e0ebd2e8 61 fields · synced Aug 3, 2026
- FDA UDI d1812c43-b1cc-4048-bf92-850792be0418 33 fields · synced May 30, 2026