Identity
- Trade Name
- PELOTA DE MANOS (GEL) AZUL/MEDIA EUDAMED
- Device Name
- TERAPIA DE LA MANO EUDAMED
- Model / Reference
- ORT-02030104 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436602174603 EUDAMED
- Basic UDI-DI
- 843660217TMWJ EUDAMED
- Direct Marketing DI
- 08436602174603 EUDAMED
- EMDN Code
- Y0503 HANDS AND FINGERS RE-EDUCATION DEVICES 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
Pelota De Manos (gel) Azul/Media by Ortotecsa, S.l. — 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 | 843660217TMWJ | Class I | Active |
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Manufacturer
- Manufacturer
- Ortotecsa, S.l.
- EUDAMED SRN
- ES-MF-000004786
Sources (1)
- EUDAMED 23971b83-5b1c-479b-9f7a-90b58b546dd0 61 fields · synced Jul 10, 2026