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Flamingo Curo
EUDAMEDFDA UDIClass I (EU MDR)
Ref 882001Model Toilet & Bath
by R82 A/S
Identity
- Trade Name
- Flamingo Curo EUDAMEDR82 FDA UDI
- Generic Name
- Bath back rest/seat FDA UDI
- Model / Reference
- Toilet & Bath EUDAMED882001 EUDAMEDFlamingo Curo SIZE-1 FDA UDI
Identifiers
- Catalog Number
- 882001 FDA UDI
- Primary DI / UDI-DI
- 05715393012275 EUDAMEDFDA UDI
- Basic UDI-DI
- 57072920912033L EUDAMED
- FDA Product Code
- INM FDA UDI
- EMDN Code
- Y093399 WASHING, BATHING AND SHOWERING DEVICES - OTHER EUDAMED
- GMDN Term
- Bath back rest/seat 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
Flamingo Curo 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 | 57072920912033L | 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 bd7d3d12-8e05-45ce-bf30-6c92285dd046 61 fields · synced Jul 24, 2026
- FDA UDI b3455fa1-9c4f-4d78-8348-dd22842f7516 33 fields · synced May 30, 2026