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Single Use Biopsy Valve
EUDAMEDClass I (EU MDR)
Ref AMH-AH-02Model AMH-AH-01Ref AMH-AH-03
Identity
- Trade Name
- Single Use Biopsy Valve EUDAMED
- Device Name
- Single Use Biopsy Valve EUDAMED
- Model / Reference
- AMH-AH-01 EUDAMEDAMH-AH-02 EUDAMEDAMH-AH-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948318927692 EUDAMED06948318912247 EUDAMED06948318927654 EUDAMED
- Basic UDI-DI
- 694831891s003QU EUDAMED
- EMDN Code
- G0380 DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I 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: Gastro-urological guidewire, single-use
Single Use Biopsy Valve by Anrei Medical (HZ) CO., LTD. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Gastro-urological guidewire, single-use.
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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 | 694831891s003QU | Class I | Active |
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Manufacturer
- Manufacturer
- Anrei Medical (HZ) Co., Ltd.
- EUDAMED SRN
- CN-MF-000009964
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (6)
- EUDAMED 9e2a428c-7279-4b37-a729-d131f727fe1d 61 fields · synced Aug 3, 2026
- EUDAMED 95ca68d6-886c-4eaf-b3f2-2a344ab4ef21 61 fields · synced May 17, 2026
- EUDAMED f6a5a610-e91c-47fd-963e-98b1fbedfc5b 61 fields · synced May 19, 2026
- EUDAMED b2d7b2a9-e85b-479a-9980-8ce8e45eef54 61 fields · synced Jun 18, 2026
- EUDAMED cffb300a-2ed6-41e4-a4aa-250aa229f882 61 fields · synced Jul 31, 2026
- EUDAMED d25887fc-a3ad-4ae4-a863-9feaba71d234 61 fields · synced Aug 3, 2026