Identity
- Model / Reference
- S31264 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974482530901 EUDAMED
- Basic UDI-DI
- B-06974482530901 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Ophthalmic surgical probe, single-use
S31264 by Ophmed Co., Ltd. — Class IIa — 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/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06974482530901 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ophmed Co., Ltd.
- EUDAMED SRN
- CN-MF-000032262
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED 65034783-f9b9-4f02-a516-4b92e483561c 61 fields · synced Jul 18, 2026