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Disposable Electrosurgical Instruments
EUDAMEDClass IIb (EU MDR)
Ref B048005330
Identity
- Trade Name
- Disposable Electrosurgical Instruments EUDAMED
- Device Name
- Disposable Electrosurgical Instruments EUDAMED
- Model / Reference
- B048005330 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974902280416 EUDAMED
- Basic UDI-DI
- 697490228B04008C EUDAMED
- EMDN Code
- K02010199 MONO- AND BIPOLAR INSTRUMENTS, SINGLE-USE - OTHER 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
Disposable Electrosurgical Instruments by Hangzhou Boer Medical Instrument 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 | 697490228B04008C | Class IIb | Active |
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Manufacturer
- Manufacturer
- Hangzhou Boer Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000015984
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (1)
- EUDAMED 5330dbbe-236b-4b5b-909c-1550434163da 61 fields · synced Jun 19, 2026