Identity
- Trade Name
- MICROSURGERY KNIFE EUDAMED
- Device Name
- MICROSURGERY KNIFE EUDAMED
- Model / Reference
- SP-U10S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04562143741210 EUDAMED
- Basic UDI-DI
- 456214374AA024N EUDAMED
- EMDN Code
- Q02010101 OPHTHALMIC MICROKNIVES, STRAIGHT 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
Microsurgery Knife by Kai Industries Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 456214374AA024N | Class IIa | Active |
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Manufacturer
- Manufacturer
- Kai Industries Co., Ltd.
- EUDAMED SRN
- JP-MF-000016663
- Authorised Representative
- Kai Europe GmbH DE-AR-000005096
Sources (1)
- EUDAMED 6834f333-1ed9-4d1e-83f5-0c88fd5c6f61 61 fields · synced Jul 12, 2026