Identity
- Trade Name
- GATEADOR GRADUABLE EUDAMED
- Device Name
- REPTACIÓN, GATEO Y POSICIONAMIENTO EUDAMED
- Model / Reference
- F.60-2N EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436602172142 EUDAMED
- Basic UDI-DI
- 843660217GPVH EUDAMED
- Direct Marketing DI
- 08436602172142 EUDAMED
- EMDN Code
- Y091299 DEJECTION DEVICES - OTHER 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
Gateador Graduable 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 | 843660217GPVH | Class I | Active |
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Manufacturer
- Manufacturer
- Ortotecsa, S.l.
- EUDAMED SRN
- ES-MF-000004786
Sources (1)
- EUDAMED 2832e8d0-1ca3-479a-9c4d-f7863f610478 61 fields · synced Jul 19, 2026