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Bores Optic Zone Marker 10.5 cm - 4 1/4" Tip Ø 6.0 mm Stainless Steel
EUDAMEDClass I (EU MDR)
Ref OP-911-10Model 50554459DIAGNOSTI020203F4
Identity
- Trade Name
- Bores Optic Zone Marker 10.5 cm - 4 1/4" Tip Ø 6.0 mm Stainless Steel EUDAMED
- Device Name
- Diagnostic Instruments EUDAMEDCorneal markers EUDAMED
- Model / Reference
- OP-911-10 EUDAMED50554459DIAGNOSTI020203F4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055445958947 EUDAMED
- Basic UDI-DI
- 50554459DIAGNOSTUV EUDAMED50554459DIAGNOSTI020203F4 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
EUDAMEDEUDAMED
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
Bores Optic Zone Marker 10.5 cm - 4 1/4" Tip Ø 6.0 mm Stainless Steel by Surtex Instruments Ltd — Class I — MDR — listed in EUDAMED
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Also classified as Corneal marker, reusable.
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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 (2)
- EUDAMED 2277892a-1812-4cb4-9e48-5123ae8d2205 61 fields · synced Oct 7, 2026
- EUDAMED a9254d8a-43f0-4363-a50d-39687ee99a00 61 fields · synced Oct 7, 2026