Identity
- Trade Name
- Orca EUDAMEDR82 FDA UDI
- Generic Name
- Portable reclining bathtub FDA UDI
- Model / Reference
- Toilet & Bath EUDAMED87550 EUDAMEDOrca ONE SIZE FDA UDI
Identifiers
- Catalog Number
- 87550 FDA UDI
- Primary DI / UDI-DI
- 05707292578099 EUDAMEDFDA UDI
- Basic UDI-DI
- 57072920933074F EUDAMED
- FDA Product Code
- ILS FDA UDI
- EMDN Code
- Y093399 WASHING, BATHING AND SHOWERING DEVICES - OTHER EUDAMED
- GMDN Term
- Portable reclining bathtub 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
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
Category: Hydrotherapy bath/tank
Orca by R82 A/S — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 57072920933074F | 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 0a4dfa8a-9f04-4670-ab7e-54ec5d558a58 61 fields · synced Jun 18, 2026
- FDA UDI 191d9754-e220-4050-bb14-52e24983a618 33 fields · synced May 30, 2026