Identity
- Device Name
- Single Use Electrosurgical Knife EUDAMED
- Model / Reference
- EK-413D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948318947829 EUDAMED
- Basic UDI-DI
- 694831892b005ML EUDAMED
- EMDN Code
- G030299 DIGESTIVE ENDOSCOPY, HAEMOSTASIS DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIb 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
Single Use Electrosurgical Knife by Anrei Medical (HZ) CO., LTD. — Class IIb — 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 | 694831892b005ML | Class IIb | Active |
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Manufacturer
- Manufacturer
- Anrei Medical (HZ) Co., Ltd.
- EUDAMED SRN
- CN-MF-000009964
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 24906be9-24f6-44e8-ade2-6de82b347be5 61 fields · synced Jun 18, 2026