Identity
- Device Name
- Cervical Ripening Balloon EUDAMED
- Model / Reference
- CRB-18F EUDAMED241001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936841212187 EUDAMED
- Basic UDI-DI
- B-06936841212187 EUDAMED
- EMDN Code
- U080199 GYNAECOLOGICAL CATHETERS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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
Cervical Ripening Balloon by Tianck Medical 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-06936841212187 | Class IIa | 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 c7729b2d-f4d4-4c58-ba30-67716d0c5232 61 fields · synced Jun 17, 2026