Identity
- Trade Name
- SAFETY KNIFE EUDAMED
- Device Name
- SAFETY KNIFE EUDAMED
- Model / Reference
- SK-CPU16 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04560146928720 EUDAMED
- Basic UDI-DI
- 456014692AD014Y EUDAMED
- EMDN Code
- Q02010102 OPHTHALMIC MICROKNIVES, ANGLED 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
Safety 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 | 456014692AD014Y | 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 0bffe8a2-3433-455c-82aa-6d100f8d906f 61 fields · synced Aug 3, 2026