← Back to catalogue
NovaSure Impedance Controlled Endometrial Ablation System RF Controller Model 10
EUDAMEDClass IIb (EU MDR)
Ref RFC2010
Identity
- Trade Name
- NovaSure Impedance Controlled Endometrial Ablation System RF Controller Model 10 EUDAMED
- Device Name
- NovaSure Impedance Controlled Endometrial Ablation System EUDAMED
- Model / Reference
- RFC2010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15420045508187 EUDAMED
- Basic UDI-DI
- 54200455GSSNOVASURERFCSJ EUDAMED
- Direct Marketing DI
- 15420045508187 EUDAMED
- EMDN Code
- Z12080201 ENDOMETRIAL ABLATION EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
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 RF Controller Model 10 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 | 54200455GSSNOVASURERFCSJ | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hologic, Inc.
- EUDAMED SRN
- US-MF-000003310
- Authorised Representative
- Hologic BV BE-AR-000000127
Sources (1)
- EUDAMED acb1d133-19a5-4e51-a86a-16c98e3a8841 61 fields · synced Jul 10, 2026