Identity
- Trade Name
- Kyphoplastic Balloon Catheters EUDAMED
- Device Name
- Kyphoplastic Balloon Catheters EUDAMED
- Model / Reference
- AP1010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942180374653 EUDAMED
- Basic UDI-DI
- B-06942180374653 EUDAMED
- EMDN Code
- N020199 SPINAL CATHETERS AND KITS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
Kyphoplastic Balloon Catheters by Shanghai MicroPort Medical (Group) 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-06942180374653 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shanghai MicroPort Medical (Group) Co., Ltd.
- EUDAMED SRN
- CN-MF-000001110
- Authorised Representative
- MicroPort Medical B.V. NL-AR-000000166
Sources (1)
- EUDAMED 0669060f-810b-48a6-a033-667194450fbf 61 fields · synced Jul 29, 2026