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Disposable vessel sealer and divider
EUDAMEDClass IIb (EU MDR)
Ref NPTModel NPT23W, NPT30W, NPT37W, NPT44W, NPT23S, NPT30S, NPT37S, NPT44S, NPT23, NPT37, NPT44, NPT23Z, NPT37Z, NPT44Z, NPTLF
Identity
- Trade Name
- Disposable vessel sealer and divider EUDAMED
- Device Name
- Disposable bipolar surgical instruments EUDAMED
- Model / Reference
- NPT23W, NPT30W, NPT37W, NPT44W, NPT23S, NPT30S, NPT37S, NPT44S, NPT23, NPT37, NPT44, NPT23Z, NPT37Z, NPT44Z, NPTLF EUDAMEDNPT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971767873234 EUDAMED
- Basic UDI-DI
- 697176787NPTZ6 EUDAMED
- EMDN Code
- K02010199 MONO- AND BIPOLAR INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
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 vessel sealer and divider by Wuxi Beien Surgery Device 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 | 697176787NPTZ6 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Wuxi Beien Surgery Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000017684
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED 787541d0-9bb1-4681-b71e-00023959a9f8 61 fields · synced Jul 11, 2026