Identity
- Trade Name
- BLAYCO EUDAMED
- Device Name
- Disposable Electrosurgical Active Electrodes EUDAMED
- Model / Reference
- HT-1/HT-N1/HT-R1,ect EUDAMEDMB-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08427734037584 EUDAMED
- Basic UDI-DI
- 69443013010000MW EUDAMED
- EMDN Code
- K0201010301,K0201010501 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain 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
Blayco by Zhejiang Jinhua Huatong Medical Appliance 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 | 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 5eb97fd0-4ccc-40e2-94b5-497acc90a0bf 61 fields · synced Oct 7, 2026