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MANOPLA SOFT (PAR) T.2 M: 7-9 cm +2 more models
EUDAMEDClass I (EU MDR)
Ref OSL1313#2
Identity
- Trade Name
- MANOPLA SOFT (PAR) T.2 M: 7-9 cm; 25,5 cm ; SOFT ANTI BEDSORE GLOVE - GREY EUDAMED
- Device Name
- Antiescaras EUDAMED
- Model / Reference
- OSL1313#2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435491802321 EUDAMED
- Basic UDI-DI
- 84350259ORL20801QA EUDAMED
- EMDN Code
- V0811 HEEL, ELBOW AND KNEE ANTI-DECUBITUS PROTECTION AIDS EUDAMED
- Models / Variants
- MANOPLA SOFT (PAR) T.2 M: 7-9 cm EUDAMED25, 5 cm EUDAMEDSOFT ANTI BEDSORE GLOVE - GREY 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
MANOPLA SOFT (PAR) T.2 M: 7-9 cm +2 more models by Orliman, S.L.U. — Class I — MDR — listed in EUDAMED — 3 models — 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 | 84350259ORL20801QA | Class I | Active |
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Manufacturer
- Manufacturer
- Orliman, S.L.U.
- EUDAMED SRN
- ES-MF-000001598
Sources (1)
- EUDAMED 70f154b7-e641-4dc1-9830-8f2d200178e0 61 fields · synced Jun 19, 2026