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Disposable Balloon Dilatation Catheters
EUDAMEDClass IIa (EU MDR)
Ref HM/301-0630-600
Identity
- Device Name
- Disposable Balloon Dilatation Catheters EUDAMED
- Model / Reference
- HM/301-0630-600 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951862292017 EUDAMED
- Basic UDI-DI
- B-06951862292017 EUDAMED
- EMDN Code
- G0301010101 OESOPHAGEAL BALLOON CATHETERS, LOW PRESSURE 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
Disposable Balloon Dilatation Catheters by Changzhou Health Microport Medical Device Co., Ltd — Class IIa — MDD — listed in EUDAMED
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-06951862292017 | 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 fa267e71-ac4e-4590-b491-882445c1f38b 61 fields · synced Oct 6, 2026