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Elliot Scleral Trephine Blade 3.5 cm - 1 1/2" Ø 1.0 mm Stainless Steel
EUDAMEDClass I (EU MDR)
Ref OP-370-10Model 50554459RONGANDIR1704014R
Identity
- Trade Name
- Elliot Scleral Trephine Blade 3.5 cm - 1 1/2" Ø 1.0 mm Stainless Steel EUDAMED
- Device Name
- Cutting Instruments EUDAMEDCorneal trephines, reusable EUDAMED
- Model / Reference
- OP-370-10 EUDAMED50554459RONGANDIR1704014R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055445956011 EUDAMED
- Basic UDI-DI
- 50554459CUTTINGINSTRL2 EUDAMEDB-05055445956011 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
Elliot Scleral Trephine Blade 3.5 cm - 1 1/2" Ø 1.0 mm Stainless Steel by Surtex Instruments Ltd — Class I — MDD, MDR — listed in EUDAMED
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Also classified as Corneoscleral punch.
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- 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 |
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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 7fa7ec37-815c-45bc-88bc-59e02a145d5d 61 fields · synced Oct 7, 2026
- EUDAMED 356c8ccc-7d20-41cc-b38d-8c7a8cd06737 61 fields · synced Oct 7, 2026