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NovaSure Impedance Controlled Endometrial Ablation System V5 Disposable Device
EUDAMEDClass IIb (EU MDR)
Ref NSV5-001
Identity
- Trade Name
- NovaSure Impedance Controlled Endometrial Ablation System V5 Disposable Device EUDAMED
- Device Name
- NovaSure Impedance Controlled Endometrial Ablation System EUDAMED
- Model / Reference
- NSV5-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15420045515154 EUDAMED
- Basic UDI-DI
- 54200455GSSNOVASURENSE6 EUDAMED
- Direct Marketing DI
- 15420045515154 EUDAMED
- EMDN Code
- Z12080201 ENDOMETRIAL ABLATION EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Belgium 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
NovaSure Impedance Controlled Endometrial Ablation System V5 Disposable Device by Hologic Inc. — Class IIb — MDR — listed in EUDAMED
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 | 54200455GSSNOVASURENSE6 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Hologic, Inc.
- EUDAMED SRN
- US-MF-000003310
- Authorised Representative
- Hologic BV BE-AR-000000127
Sources (1)
- EUDAMED 2ed3fbcd-ad2a-4e21-89b6-19fe665f19df 61 fields · synced Jun 19, 2026