Identity
- Trade Name
- HUATONG EUDAMED
- Device Name
- Disposable Electrosurgical Active Electrodes EUDAMED
- Model / Reference
- HT-1/HT-N1/HT-R1,ect EUDAMEDHT-1-B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944301300299 EUDAMED
- Basic UDI-DI
- 69443013010000MW EUDAMED
- EMDN Code
- K0201010501 OPEN ELECTROSURGERY HANDPIECES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye 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
Category: Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Huatong by Zhejiang Jinhua Huatong Medical Appliance Co., Ltd — Class IIb — 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 | 69443013010000MW | Class IIb | Active |
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Manufacturer
- Manufacturer
- Zhejiang Jinhua Huatong Medical Appliance Co., Ltd
- EUDAMED SRN
- CN-MF-000010166
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 036ae72c-4a60-4b1c-960b-643887220982 61 fields · synced Oct 6, 2026