Identity
- Trade Name
- MOBILE WHIRLPOOL (170L) - 220V FDA UDI
- Generic Name
- Hydrotherapy bath/tank FDA UDI
- Device Name
- ACCESORIOS Y COMPLEMENTOS EUDAMED
- Model / Reference
- C.5 EUDAMEDG.18951/D FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08436602170117 EUDAMEDFDA UDI
- Basic UDI-DI
- 843660217ACU5 EUDAMED
- Direct Marketing DI
- 08436602170117 EUDAMED
- FDA Product Code
- ILJ FDA UDI
- EMDN Code
- Y0999 PERSONAL CARE AIDS - OTHER EUDAMED
- GMDN Term
- Hydrotherapy bath/tank FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.5100 FDA UDI
- Market of Registration
- Spain 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
Accesorios Y Complementos by Ortotecsa, S.l. — 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 | 843660217ACU5 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ortotecsa, S.l.
- EUDAMED SRN
- ES-MF-000004786
Sources (2)
- EUDAMED 61d6067d-9495-49b7-873b-73852db67800 61 fields · synced Jul 31, 2026
- FDA UDI 18d31f97-08de-4b78-bf59-f21144657115 32 fields · synced May 30, 2026