Identity
- Trade Name
- IS-1P (left RAL 9001) EUDAMED
- Device Name
- Unidad de refracción / Refraction Unit EUDAMED
- Model / Reference
- IS EUDAMED1202511 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436566190831 EUDAMED
- Basic UDI-DI
- 8436566193REFH6 EUDAMED
- EMDN Code
- Z12120119 OPHTHALMOLOGICAL TREATMENT UNITS 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
IS-1P (left RAL 9001) by Antoni Carles S.a. — 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 | 8436566193REFH6 | Class I | Active |
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Manufacturer
- Manufacturer
- Antoni Carles S.a.
- EUDAMED SRN
- ES-MF-000001010
Sources (1)
- EUDAMED b0b55e4f-6d03-4f8b-bd4a-28977cc1768c 61 fields · synced Jul 10, 2026