Identity
- Trade Name
- HYSTEROSCOPE EUDAMED
- Device Name
- Hysteroscope EUDAMED
- Model / Reference
- 8300051673 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04035873076582 EUDAMED
- Basic UDI-DI
- 4035873120101059Y EUDAMED
- Direct Marketing DI
- 04035873076582 EUDAMED
- EMDN Code
- Z12020704 HYSTEROSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Category: Rigid video hysteroscope
Hysteroscope by Henke-Sass, Wolf GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 4035873120101059Y | Class IIa | Active |
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Manufacturer
- Manufacturer
- Henke-Sass, Wolf GmbH
- EUDAMED SRN
- DE-MF-000005531
Sources (1)
- EUDAMED 72c2bbd0-f387-493b-8a29-0c12ce70118c 61 fields · synced May 23, 2026