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Single-Use Hysteroscope
EUDAMEDClass IIa (EU MDR)
Ref AE-H6000Model Single-Use HysteroscopeRef AE-H6030
Identity
- Trade Name
- Single-Use Hysteroscope EUDAMED
- Device Name
- Single-Use Hysteroscope EUDAMED
- Model / Reference
- Single-Use Hysteroscope EUDAMEDAE-H6000 EUDAMEDAE-H6030 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942127878954 EUDAMED06942127878961 EUDAMED
- Basic UDI-DI
- 697067138HS049GJ EUDAMED
- EMDN Code
- Z12020704 HYSTEROSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Category: Rigid video hysteroscope
Single-Use Hysteroscope by Alton (Shanghai) Medical Instruments Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Rigid video hysteroscope.
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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 | 697067138HS049GJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Alton (Shanghai) Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000012832
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 0467c8ab-cd83-4f1c-a75c-162a67b763bc 61 fields · synced Oct 6, 2026
- EUDAMED 7747b7c4-c5df-4b9c-a00a-1227e4060870 61 fields · synced Jul 17, 2026