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Disposable Electrosurgical Active Electrodes
EUDAMEDClass IIb (EU MDR)
Ref HT-1Model HT-1/HT-N1/HT-R1,ectRef HT-N1-TRef HT-N1-5Ref HT-R1Ref HT-R1-5Ref HT-R1-TRef HT-N1Ref HT-1-DRef HT-1-5
Identity
- Device Name
- Disposable Electrosurgical Active Electrodes EUDAMED
- Model / Reference
- HT-1/HT-N1/HT-R1,ect EUDAMEDHT-1 EUDAMEDHT-N1-T EUDAMEDHT-N1-5 EUDAMEDHT-R1 EUDAMEDHT-R1-5 EUDAMEDHT-R1-T EUDAMEDHT-N1 EUDAMEDHT-1-D EUDAMEDHT-1-5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944301300022 EUDAMED06944301301074 EUDAMED06944301301081 EUDAMED06944301303665 EUDAMED06944301303672 EUDAMED06944301303689 EUDAMED06944301300336 EUDAMED06944301303740 EUDAMED06944301303733 EUDAMED
- Basic UDI-DI
- 69443013010000MW EUDAMED
- EMDN Code
- K0201010501 OPEN ELECTROSURGERY HANDPIECES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Denmark EUDAMEDItaly EUDAMEDGermany EUDAMEDSpain 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
Disposable Electrosurgical Active Electrodes by Zhejiang Jinhua Huatong Medical Appliance Co., Ltd — Class IIb — MDR — listed in EUDAMED
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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 (9)
- EUDAMED f880de40-d616-463b-b399-3e446c133ebf 61 fields · synced Aug 1, 2026
- EUDAMED a8c4df39-4bb6-486f-84d9-a33503bf5c45 61 fields · synced May 17, 2026
- EUDAMED ffe0b650-5652-4e66-869e-19e27a211666 61 fields · synced May 18, 2026
- EUDAMED 16478a78-2b1b-4e2f-9386-1f90c9c66dac 61 fields · synced May 18, 2026
- EUDAMED 1453a858-5ee9-4181-a77a-816f6a252292 61 fields · synced May 18, 2026
- EUDAMED 6606c234-c7cf-4d33-8194-f31c926b7450 61 fields · synced May 19, 2026
- EUDAMED 20fdf3ff-73e2-470e-88fa-9ac355cd9e1a 61 fields · synced May 19, 2026
- EUDAMED 0d334414-75cb-4bda-afbf-231a1a8fdbfd 61 fields · synced Jun 20, 2026
- EUDAMED 8f11cb40-fea0-4962-9f84-8e568dbe6c08 61 fields · synced Jul 11, 2026