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Sterile single use electrosurgical pencil
EUDAMEDClass IIb (EU MDR)
Ref HCP-05
by WickiMed (HuiZhou) Medical Equipment Manufacturing Co., Ltd
Identity
- Trade Name
- Sterile single use electrosurgical pencil EUDAMED
- Device Name
- Sterile single use electrosurgical pencil EUDAMED
- Model / Reference
- HCP-05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970739453863 EUDAMED
- Basic UDI-DI
- B-06970739453863 EUDAMED
- EMDN Code
- K0201010201 OPEN ELECTROSURGERY DISSECTORS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Austria 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
Sterile single use electrosurgical pencil by WickiMed (HuiZhou) Medical Equipment Manufacturing Co., Ltd — Class IIb — MDD — listed in EUDAMED
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-06970739453863 | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000027477
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 9a381e67-8339-4cb9-9d01-78774e99602c 61 fields · synced Jun 19, 2026