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Guide Wires
EUDAMEDClass IIa (EU MDR)
Ref HM/109-0.032"/4500LModel HM/109-0.032"/4500L
Identity
- Device Name
- Guide Wires EUDAMED
- Model / Reference
- HM/109-0.032"/4500L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951862218017 EUDAMED
- Basic UDI-DI
- B-06951862218017 EUDAMED
- EMDN Code
- G030899 INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Guide Wires by Changzhou Health Microport Medical Device Co., Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06951862218017 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Changzhou Health Microport Medical Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000033536
- Authorised Representative
- Llins Service & Consulting GmbH DE-AR-000009077
Sources (1)
- EUDAMED da529dc4-cbaa-4e19-8b26-7fa7c9808f31 61 fields · synced Jun 18, 2026