← Back to catalogue
Hoffer Optic Zone Marker With Cross Hairs 10.5 cm - 4 1/4" Tip Ø 8.0 mm Stainle…
EUDAMEDClass I (EU MDR)
Ref OP-913-13
Identity
- Trade Name
- Hoffer Optic Zone Marker With Cross Hairs 10.5 cm - 4 1/4" Tip Ø 8.0 mm Stainless Steel EUDAMED
- Device Name
- Diagnostic Instruments EUDAMED
- Model / Reference
- OP-913-13 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055445959104 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
Hoffer Optic Zone Marker With Cross Hairs 10.5 cm - 4 1/4" Tip Ø 8.0 mm Stainle… by Surtex Instruments Ltd — Class I — MDR — listed in EUDAMED
Similar devices
Also classified as Corneal marker, reusable.
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- MR PHACO — Crestpoint Management Ltd. · Class I
- ICHIKAWA OPTIC ZONE MARKER — Katena Products, Inc. · Class I
- SLADE ARCUATE MARKER 45 DEGREE — Katena Products, Inc. · Class I
- Hoffer Optic Zone Marker, with Cross Hairs, 3.0mm — KATALYST SURGICAL, LLC · Class I
- Marker, Ocular — Katena Products, Inc. · Class I
- Double End Martinel Corneal Dissector — DAUD JEE MFG. CO · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Surtex Instruments Ltd
- EUDAMED SRN
- GB-MF-000023183
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 6275cbdc-0c88-46a4-891c-fa704c93d012 61 fields · synced May 29, 2026