Identity
- Device Name
- Balloon inflation devices EUDAMED
- Model / Reference
- BT40HV EUDAMED104006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936841202010 EUDAMED
- Basic UDI-DI
- B-06936841202010 EUDAMED
- EMDN Code
- C0104010280 INTERVENTIONAL CORONARY ANGIOGRAPHY DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Balloon inflation devices by Tianck Medical 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-06936841202010 | Class I | Active |
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Manufacturer
- Manufacturer
- Tianck Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000007451
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 6fdf3647-a5e6-4787-9263-2ee611e4f0d0 61 fields · synced Jun 19, 2026