Identity
- Trade Name
- DERMAL CURETTE 3 mm EUDAMED
- Device Name
- DERMAL CURETTE EUDAMED
- Model / Reference
- MK403 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04560146928478 EUDAMED
- Basic UDI-DI
- 456014692AC014T EUDAMED
- EMDN Code
- A01020303 CUTANEOUS BIOPSY CURETTES, 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
Yes
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: Dermal curette, single-use
DERMAL CURETTE 3 mm by Kai Industries Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 456014692AC014T | 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 934f3e6b-d203-4c77-8321-ea35778f479d 61 fields · synced Jun 18, 2026