Identity
- Trade Name
- BOTA SOFT (PAR) T.3 M: 44-47 EUDAMED
- Device Name
- Heel, elbow and knee anti-decubitus protection aids EUDAMED
- Model / Reference
- OSL1316#3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435491801973 EUDAMED
- Basic UDI-DI
- 84350259ORL20802QC EUDAMED
- EMDN Code
- V0811 HEEL, ELBOW AND KNEE ANTI-DECUBITUS PROTECTION AIDS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Bota Soft (par) T.3 M: 44-47 by Orliman, S.L.U. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 84350259ORL20802QC | Class I | Active |
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Manufacturer
- Manufacturer
- Orliman, S.L.U.
- EUDAMED SRN
- ES-MF-000001598
Sources (1)
- EUDAMED 0dbc6ce3-2d8a-412b-b085-4c24d590a633 61 fields · synced Aug 4, 2026