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Introducer sets
EUDAMEDClass IIa (EU MDR)
Ref 054008Model Hydrophilic Coated Radial Sheath 7Fx11CM
Identity
- Device Name
- Introducer sets EUDAMED
- Model / Reference
- Hydrophilic Coated Radial Sheath 7Fx11CM EUDAMED054008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936841200979 EUDAMED
- Basic UDI-DI
- B-06936841200979 EUDAMED
- EMDN Code
- C0502 CARDIOVASCULAR INTRODUCER SHEATHS, VALVED EUDAMED
Classification
- Device Class
- Class IIa 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Introducer sets 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-06936841200979 | 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 741737c8-5708-4d3b-8b94-14b6923b4920 61 fields · synced Jun 19, 2026