Identity
- Trade Name
- Gonnin Amsler Marker Stainless Steel EUDAMED
- Device Name
- Diagnostic Instruments EUDAMED
- Model / Reference
- OP-163-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056111321461 EUDAMED
- Basic UDI-DI
- 50554459DIAGNOSTUV EUDAMED
- EMDN Code
- Q020203 CORNEAL MARKERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Category: Corneal marker, reusable
Gonnin Amsler Marker Stainless Steel by Surtex Instruments Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 50554459DIAGNOSTUV | Class I | Active |
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Manufacturer
- Manufacturer
- Surtex Instruments Ltd
- EUDAMED SRN
- GB-MF-000023183
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 742c5e0f-8d38-4000-97b1-142a24e849f9 61 fields · synced Jul 9, 2026