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Bores Optic Zone Marker 10.5 cm - 4 1/4" Tip Ø 8.0 mm Stainless Steel
EUDAMEDClass I (EU MDR)
Ref OP-911-12Ref OP-911-01Ref OP-911-08Ref OP-911-02Ref OP-911-07Ref OP-911-05Ref OP-911-11
Identity
- Trade Name
- Bores Optic Zone Marker 10.5 cm - 4 1/4" Tip Ø 8.0 mm Stainless Steel EUDAMEDBores Optic Zone Marker 10.5 cm - 4 1/4" Tip Ø 3.0 mm Stainless Steel EUDAMEDBores Optic Zone Marker 10.5 cm - 4 1/4" Tip Ø 4.75 mm Stainless Steel EUDAMEDBores Optic Zone Marker 10.5 cm - 4 1/4" Tip Ø 3.25 mm Stainless Steel EUDAMEDBores Optic Zone Marker 10.5 cm - 4 1/4" Tip Ø 4.5 mm Stainless Steel EUDAMEDBores Optic Zone Marker 10.5 cm - 4 1/4" Tip Ø 4.0 mm Stainless Steel EUDAMEDBores Optic Zone Marker 10.5 cm - 4 1/4" Tip Ø 7.0 mm Stainless Steel EUDAMED
- Device Name
- Diagnostic Instruments EUDAMED
- Model / Reference
- OP-911-12 EUDAMEDOP-911-01 EUDAMEDOP-911-08 EUDAMEDOP-911-02 EUDAMEDOP-911-07 EUDAMEDOP-911-05 EUDAMEDOP-911-11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055445958961 EUDAMED05055445958855 EUDAMED05055445958923 EUDAMED05055445958862 EUDAMED05055445958916 EUDAMED05055445958893 EUDAMED05055445958954 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
Bores Optic Zone Marker 10.5 cm - 4 1/4" Tip Ø 8.0 mm Stainless Steel by Surtex Instruments Ltd — Class I — MDR — listed in EUDAMED
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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 (7)
- EUDAMED d865dc2f-3ca0-4838-be4c-82123f06d0b7 61 fields · synced Oct 6, 2026
- EUDAMED 67c76a3c-ba2b-4ed1-8748-f736eb31ce13 61 fields · synced May 16, 2026
- EUDAMED a0ad1d13-a386-4374-ad83-706a004a7cea 61 fields · synced May 17, 2026
- EUDAMED 1fa73a8c-5c5e-40a5-9c50-8af02e01d7bd 61 fields · synced May 18, 2026
- EUDAMED b182afeb-cc30-431a-8139-2c56489775a4 61 fields · synced May 18, 2026
- EUDAMED 1f554732-072b-4b57-a1a1-cdf78d5d874d 61 fields · synced May 19, 2026
- EUDAMED 068cf396-940d-43ff-a0e8-342b06f0ea53 61 fields · synced May 19, 2026