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Introducer sets
EUDAMEDClass IIa (EU MDR)
Ref 057002Model Hydrophilic Coated Femoral Sheath 5FX11CMRef 054003Model Hydrophilic Coated Radial Sheath 6Fx10CMRef 057003Model Hydrophilic Coated Femoral Sheath 6FX11CMRef 057005Model Hydrophilic Coated Femoral Sheath 8FX11CMRef 054004Model Hydrophilic Coated Radial Sheath 7Fx10CMRef 054006Model Hydrophilic Coated Radial Sheath 5Fx11CMRef 054001Model Hydrophilic Coated Radial Sheath 4Fx10CM
Identity
- Device Name
- Introducer sets EUDAMED
- Model / Reference
- Hydrophilic Coated Femoral Sheath 5FX11CM EUDAMED057002 EUDAMEDHydrophilic Coated Radial Sheath 6Fx10CM EUDAMED054003 EUDAMEDHydrophilic Coated Femoral Sheath 6FX11CM EUDAMED057003 EUDAMEDHydrophilic Coated Femoral Sheath 8FX11CM EUDAMED057005 EUDAMEDHydrophilic Coated Radial Sheath 7Fx10CM EUDAMED054004 EUDAMEDHydrophilic Coated Radial Sheath 5Fx11CM EUDAMED054006 EUDAMEDHydrophilic Coated Radial Sheath 4Fx10CM EUDAMED054001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936841200993 EUDAMED06971162818557 EUDAMED06936841201006 EUDAMED06936841201020 EUDAMED06971162818564 EUDAMED06936841200955 EUDAMED06971162817628 EUDAMED
- Basic UDI-DI
- B-06936841200993 EUDAMEDB-06971162818557 EUDAMEDB-06936841201006 EUDAMEDB-06936841201020 EUDAMEDB-06971162818564 EUDAMEDB-06936841200955 EUDAMEDB-06971162817628 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
Category: Vascular catheter introduction set, nonimplantable
Introducer sets by Tianck Medical Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-06936841200993 | 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 (7)
- EUDAMED 60e276f9-27d9-4628-bd53-bf83f7c1c9f8 61 fields · synced Oct 7, 2026
- EUDAMED 89e0bb1e-facb-4d57-bf83-a066ea454c2c 61 fields · synced May 17, 2026
- EUDAMED b31f9bd6-3318-40c9-b2bc-5c25bd000273 61 fields · synced May 18, 2026
- EUDAMED 9f593cb2-24cc-47ad-80ef-538f864d8461 61 fields · synced May 18, 2026
- EUDAMED c67de8ae-f827-4b71-8ccc-a0a11a9278d2 61 fields · synced May 18, 2026
- EUDAMED 4aadd55f-8c2f-49e3-a34f-17a81e7f9fc5 61 fields · synced May 19, 2026
- EUDAMED 051b1a31-f428-4394-8770-cf37282a2f73 61 fields · synced May 19, 2026