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Primelife
EUDAMEDClass IIa (EU MDR)
Ref 052170Model Femoral 4F, Femoral 5F, Femoral 6F, Femoral 7F, Femoral 8F, Femoral 9F, Femoral 10F, Femoral 11F, Femoral 12F, Radial 3F, Radial 4F, Radial 5F, Radial 6F, Radial 7F, Radial 8FRef 051125Ref 052168Ref 052167Ref 051124Ref PRIMELIFEModel TB-03LRef 052169Ref 123004Model MSRef 111010Model HVRef 157090Model Straight tip, J tip, Angle tipRef 061010Model 12mlRef 159102Ref 158147Model Hydrophilic 0.035x180cm JRef 157092Model Hydrophilic 0.032x260cm J
Identity
- Trade Name
- PRIMELIFE EUDAMED
- Device Name
- Introducer Sheath EUDAMEDRadial Artery Closure Band EUDAMEDManifold Set EUDAMEDHemostasis Valve EUDAMEDGuidewire EUDAMEDDose Control Syringe EUDAMED
- Model / Reference
- Femoral 4F, Femoral 5F, Femoral 6F, Femoral 7F, Femoral 8F, Femoral 9F, Femoral 10F, Femoral 11F, Femoral 12F, Radial 3F, Radial 4F, Radial 5F, Radial 6F, Radial 7F, Radial 8F EUDAMED052170 EUDAMED051125 EUDAMED052168 EUDAMED052167 EUDAMED051124 EUDAMEDTB-03L EUDAMEDPRIMELIFE EUDAMED052169 EUDAMEDMS EUDAMED123004 EUDAMEDHV EUDAMED111010 EUDAMEDStraight tip, J tip, Angle tip EUDAMED157090 EUDAMED12ml EUDAMED061010 EUDAMED159102 EUDAMEDHydrophilic 0.035x180cm J EUDAMED158147 EUDAMEDHydrophilic 0.032x260cm J EUDAMED157092 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936841238828 EUDAMED06936841238842 EUDAMED06936841238804 EUDAMED06936841238798 EUDAMED06936841238835 EUDAMED06936841238910 EUDAMED06936841238811 EUDAMED06936841238903 EUDAMED06936841238880 EUDAMED06936841238637 EUDAMED06936841238897 EUDAMED06936841238675 EUDAMED06936841238705 EUDAMED06936841238699 EUDAMED
- Basic UDI-DI
- 69368412IS05TV EUDAMEDB-06936841238910 EUDAMEDB-06936841238903 EUDAMED69368412HV11TY EUDAMED697116281GW15GY EUDAMEDB-06936841238897 EUDAMEDB-06936841238705 EUDAMEDB-06936841238699 EUDAMED
- EMDN Code
- C0504 ARTERIAL INTRODUCTION SETS EUDAMEDC90010301 HAEMOSTASIS MECHANICAL SYSTEMS (INCLUDING SINGLE-USE TOURNIQUETS) EUDAMEDA03040199 INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER EUDAMEDC900101 HAEMOSTASIS VALVES EUDAMEDC04020102 PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC EUDAMEDA02010401 SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE EUDAMEDC04020101 PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMEDEUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Interventional radiology percutaneous-access kit, single-use
Primelife by Tianck Medical Co., Ltd. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Interventional radiology percutaneous-access kit, single-use.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69368412IS05TV | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | 69368412IS05TV | 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 (14)
- EUDAMED 0a1dd431-f3fb-45e2-95dc-570fb964fcd2 61 fields · synced Aug 3, 2026
- EUDAMED bb5c0091-ffec-4846-896f-e722eca1cda1 61 fields · synced May 16, 2026
- EUDAMED f628cfd7-83cc-4a46-971e-f45a8a543f02 61 fields · synced May 16, 2026
- EUDAMED fa311715-14b0-47f1-b4f3-fe9ff974ca6e 61 fields · synced May 17, 2026
- EUDAMED ca6532b5-48aa-46e3-a661-74c0570bd4f0 61 fields · synced May 17, 2026
- EUDAMED 8d0e2894-0f84-4abf-b894-445589d06424 61 fields · synced May 17, 2026
- EUDAMED 79a089cc-b079-4774-b81c-37af4e2585b1 61 fields · synced May 18, 2026
- EUDAMED 7104320b-d95b-474d-b9ac-f3e14aa4e84e 61 fields · synced May 18, 2026
- EUDAMED 6f04dc6a-da1d-473c-9d76-43497647a7f1 61 fields · synced May 18, 2026
- EUDAMED 08c2a06d-6139-4bd2-b3d5-8ea593b1dcfd 61 fields · synced May 18, 2026
- EUDAMED 8a20d18e-b5f8-46cd-9b30-4927a0561e12 61 fields · synced May 19, 2026
- EUDAMED 939cb2de-c130-48ee-8653-122f95ab92c4 61 fields · synced May 19, 2026
- EUDAMED 7400506a-6393-444f-82a5-449e5bd0fb11 61 fields · synced Jul 21, 2026
- EUDAMED 88695ae8-af97-4fa5-8668-5718b7366944 61 fields · synced Aug 3, 2026