← Back to catalogue
Corneal Trephine Handle Ø 6.0 mm Stainless Steel
EUDAMEDClass I (EU MDR)
Ref OP-401-01Model 50554459RONGANDIR1704014R
Identity
- Trade Name
- Corneal Trephine Handle Ø 6.0 mm Stainless Steel EUDAMED
- Device Name
- Cutting Instruments EUDAMEDCorneal trephines, reusable EUDAMED
- Model / Reference
- OP-401-01 EUDAMED50554459RONGANDIR1704014R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055445956301 EUDAMED
- Basic UDI-DI
- 50554459CUTTINGINSTRL2 EUDAMEDB-05055445956301 EUDAMED
- EMDN Code
- L170401 CORNEAL TREPHINES, REUSABLE 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: Corneoscleral punch
Corneal Trephine Handle Ø 6.0 mm Stainless Steel by Surtex Instruments Ltd — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Corneoscleral punch.
- MILLENNIUM — AVALIGN TECHNOLOGIES, Inc. · Class I
- Punches — AURORA SURGICAL, LLC · Class I
- ASELTECH — Asel Tibbi Aletler A.S. · Class I
- Stephens Instruments — KRISHNA IMPORTS INC · Class I
- Wexler Surgical, Inc. — Wexler Surgical, Inc. · Class I
- ATLAS — ATLAS CERRAHİ ALETLER LTD. ŞTİ. · Class I
- V. Mueller — STERIS CORPORATION · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 50554459CUTTINGINSTRL2 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 50554459CUTTINGINSTRL2 | 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 (2)
- EUDAMED 45d59592-dac4-41d7-b8e3-d6fe5395467f 61 fields · synced Sep 30, 2026
- EUDAMED d2143660-781d-4821-8dbb-39d65ff76c6c 61 fields · synced Sep 30, 2026