Identity
- Device Name
- Biopsy Valves EUDAMED
- Model / Reference
- HM/801-O-B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951862218260 EUDAMED
- Basic UDI-DI
- B-06951862218260 EUDAMED
- EMDN Code
- Z12029099 VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI–INVASIVE SURGERY – OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Biopsy Valves by Changzhou Health Microport Medical Device Co., Ltd — Class I — 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-06951862218260 | Class I | 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 d5c06d42-921c-4bb1-acb7-16c4c0bca77b 61 fields · synced Oct 6, 2026