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Single Use Endoscope Valves set
EUDAMEDClass I (EU MDR)
Ref AMH-EV-02Ref AMH-EV-03
Identity
- Trade Name
- Single Use Endoscope Valves set EUDAMED
- Device Name
- Single Use Endoscope Valves Set EUDAMED
- Model / Reference
- AMH-EV-02 EUDAMEDAMH-EV-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948318964130 EUDAMED06948318964147 EUDAMED
- Basic UDI-DI
- 694831891s002QS 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 Endoscope Valves set by Anrei Medical (HZ) CO., LTD. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Gastro-urological guidewire, single-use.
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- Optimos™ Guidewire — Taewoong Medical · Class II
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 | 694831891s002QS | 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 (2)
- EUDAMED 3e4aa4da-08e4-4d6b-9f4c-450a6793624c 61 fields · synced Sep 18, 2026
- EUDAMED 009d3601-5802-4c0c-a0b1-4110e6c4c97b 61 fields · synced May 17, 2026