Identity
- Device Name
- Disposable Ophthalmic Hooks EUDAMED
- Model / Reference
- S14136 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974482530673 EUDAMED
- Basic UDI-DI
- B-06974482530673 EUDAMED697448253S14000AH EUDAMED
- EMDN Code
- Q021104 OPHTHALMIC SURGERY MANIPULATORS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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: Ophthalmic surgical probe, single-use
S14136 by Ophmed Co., Ltd. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic surgical probe, single-use.
- HASA OPTIX — Hasa Optix · Class IIa
- HASA OPTIX — Hasa Optix · Class IIa
- Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I
- HASA OPTIX — Hasa Optix · Class IIa
- HASA OPTIX — Hasa Optix · Class IIa
- Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I
- HASA OPTIX — Hasa Optix · Class IIa
- Epithelial Spatula — BLINK MEDICAL LIMITED · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06974482530673 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06974482530673 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ophmed Co., Ltd.
- EUDAMED SRN
- CN-MF-000032262
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (2)
- EUDAMED 4125e221-2e2b-403c-a563-03c5635ff2ee 61 fields · synced Jul 16, 2026
- EUDAMED 7934a2ac-bf8b-4bac-842f-5fd513bf35be 61 fields · synced May 18, 2026