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Introducer Set
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref IS01Model 4F, 5F, 6F, 7F, 8FRef CTR04CRRef BRN06ARef TR01ARRef NIS05BRef TR04FRef TR04CRef CTRM01BRef TR03RRef BRS07CRef MI4F02Ref ISM03Ref HIS04Ref MI4F40Ref MI5F01Ref NIS01BRef CTR03ARRef ISM01ARef MI5F03Ref NIS04ARef CHTR03ARRef HTR03CRRef CHTR03ARef TR02ARRef ISC02CRef IS03ARef CIS04Ref BRS06ARef IS01ARef ISC01ARef HTR04ARef CTR04ARRef MI4F04Ref HIS01Ref IS03CRef IS04ARef CHTRM01Ref MI4F01Ref MI5F04Ref HNIS03ARef NIS03BRef ISC04BRef CHIS03Ref CTR04RRef BRI04CRef TR02RRef BRN04ARef MI4F06Ref NIS02BRef BRS04BRef CHIS04Ref ISC03BRef NIS05ERef TR02ARef MI5F30Ref BRN04BRef TR03Ref HIS02Ref TR00ARef TR01DRef HIS03Ref CHTR04ARef BRS06BRef TR03CRef BRN05ARef HTR03ARRef IS02Ref CTRM01ARef TR03ARef TRM01BRef ISM04Ref TRM01ARef CIS01Ref ISC03CRef TRM02BRef TR01RRef TR02BRef HTR03ARef TR01CRef ISC02BRef NIS01Ref TRM02ARef BRN07CRef NIS02ASRef BRS06CRef MI5F06Ref IS01CRef IS04Ref MI4F30Ref TR01ARef ISC01CRef MI4F03Ref MI5F07Ref HTR04CRef BRS07BRef BRS07ARef BRI07ARef CTR03RRef CHTR04Ref HTR04ARRef HTR03CRef CHTR04RRef NIS03Ref CTRM02BRef CHTR04ARRef MI5F10Ref BRI05ARef CTR04CRef IS02BRef BRS05CRef MI4F60Ref CTR03CRRef BRI04BRef ISC02ARef TR03ARRef NIS04Ref NIS05DRef CIS02Ref MI5F05Ref TR02CRef IS02ARef ISM03BRef TR04BRef IS01B
Identity
- Trade Name
- Introducer Set EUDAMEDINT or KDL FDA UDIINT FDA UDI
- Generic Name
- Interventional radiology percutaneous-access kit, single-use FDA UDI
- Device Name
- Introducer Set EUDAMEDInterventional radiology percutaneous-access procedure kit. FDA UDI
- Model / Reference
- 4F, 5F, 6F, 7F, 8F EUDAMEDIS01 EUDAMEDFDA UDINIS04 EUDAMEDFDA UDIHTR03A EUDAMEDFDA UDICHTR04A EUDAMEDFDA UDIIS02A EUDAMEDFDA UDICHTR04 EUDAMEDFDA UDIIS02 EUDAMEDFDA UDITR03 EUDAMEDFDA UDIHTR04A EUDAMEDFDA UDIIS03C EUDAMEDFDA UDIIS01C EUDAMEDFDA UDIIS03A EUDAMEDFDA UDINIS04A EUDAMEDFDA UDIIS04 EUDAMEDFDA UDIIS01B EUDAMEDFDA UDIHNIS03A EUDAMEDFDA UDINIS03B EUDAMEDFDA UDINIS03 EUDAMEDFDA UDIIS04A EUDAMEDFDA UDINIS02B EUDAMEDFDA UDIIS01A EUDAMEDFDA UDINIS01 EUDAMEDFDA UDINIS05D EUDAMEDFDA UDITR03A EUDAMEDFDA UDINIS01B EUDAMEDFDA UDICHTR03A EUDAMEDFDA UDIIS02B EUDAMEDFDA UDICTR04CR EUDAMEDBRN06A EUDAMEDTR01AR EUDAMEDNIS05B EUDAMEDTR04F EUDAMEDTR04C EUDAMEDCTRM01B EUDAMEDTR03R EUDAMEDBRS07C EUDAMEDMI4F02 EUDAMEDISM03 EUDAMEDHIS04 EUDAMEDMI4F40 EUDAMEDMI5F01 EUDAMEDCTR03AR EUDAMEDISM01A EUDAMEDMI5F03 EUDAMEDCHTR03AR EUDAMEDHTR03CR EUDAMEDTR02AR EUDAMEDISC02C EUDAMEDCIS04 EUDAMEDBRS06A EUDAMEDISC01A EUDAMEDCTR04AR EUDAMEDMI4F04 EUDAMEDHIS01 EUDAMEDCHTRM01 EUDAMEDMI4F01 EUDAMEDMI5F04 EUDAMEDISC04B EUDAMEDCHIS03 EUDAMEDCTR04R EUDAMEDBRI04C EUDAMEDTR02R EUDAMEDBRN04A EUDAMEDMI4F06 EUDAMEDBRS04B EUDAMEDCHIS04 EUDAMEDISC03B EUDAMEDNIS05E EUDAMEDTR02A EUDAMEDMI5F30 EUDAMEDBRN04B EUDAMEDHIS02 EUDAMEDTR00A EUDAMEDTR01D EUDAMEDHIS03 EUDAMEDBRS06B EUDAMEDTR03C EUDAMEDBRN05A EUDAMEDHTR03AR EUDAMEDCTRM01A EUDAMEDTRM01B EUDAMEDISM04 EUDAMEDTRM01A EUDAMEDCIS01 EUDAMEDISC03C EUDAMEDTRM02B EUDAMEDTR01R EUDAMEDTR02B EUDAMEDTR01C EUDAMEDISC02B EUDAMEDTRM02A EUDAMEDBRN07C EUDAMEDNIS02AS EUDAMEDBRS06C EUDAMEDMI5F06 EUDAMEDMI4F30 EUDAMEDTR01A EUDAMEDISC01C EUDAMEDMI4F03 EUDAMEDMI5F07 EUDAMEDHTR04C EUDAMEDBRS07B EUDAMEDBRS07A EUDAMEDBRI07A EUDAMEDCTR03R EUDAMEDHTR04AR EUDAMEDHTR03C EUDAMEDCHTR04R EUDAMEDCTRM02B EUDAMEDCHTR04AR EUDAMEDMI5F10 EUDAMEDBRI05A EUDAMEDCTR04C EUDAMEDBRS05C EUDAMEDMI4F60 EUDAMEDCTR03CR EUDAMEDBRI04B EUDAMEDISC02A EUDAMEDTR03AR EUDAMEDCIS02 EUDAMEDMI5F05 EUDAMEDTR02C EUDAMEDISM03B EUDAMEDTR04B EUDAMED
- Description
- Interventional radiology percutaneous-access procedure kit. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06950900920561 EUDAMEDFDA UDI06950900961977 EUDAMEDFDA UDI06950900926334 EUDAMEDFDA UDI06950900926396 EUDAMEDFDA UDI06950900952586 EUDAMEDFDA UDI06950900961588 EUDAMEDFDA UDI06950900920295 EUDAMEDFDA UDI06950900921117 EUDAMEDFDA UDI06950900926358 EUDAMEDFDA UDI06950900961083 EUDAMEDFDA UDI06950900961830 EUDAMEDFDA UDI06950900926440 EUDAMEDFDA UDI06950900961984 EUDAMEDFDA UDI06950900920318 EUDAMEDFDA UDI06950900961823 EUDAMEDFDA UDI06950900961090 EUDAMEDFDA UDI06950900961922 EUDAMEDFDA UDI06950900922312 EUDAMEDFDA UDI06950900961953 EUDAMEDFDA UDI06950900961878 EUDAMEDFDA UDI06950900961816 EUDAMEDFDA UDI06950900961847 EUDAMEDFDA UDI06950900961779 EUDAMEDFDA UDI06950900921124 EUDAMEDFDA UDI06950900961861 EUDAMEDFDA UDI06950900926372 EUDAMEDFDA UDI06950900961885 EUDAMEDFDA UDI06950900941061 EUDAMED06950900999789 EUDAMED06950900940828 EUDAMED06950900906121 EUDAMED06950900901935 EUDAMED06950900940927 EUDAMED06942033969104 EUDAMED06950900940866 EUDAMED06950900999758 EUDAMED06950900903779 EUDAMED06950900999482 EUDAMED06950900926037 EUDAMED06950900903939 EUDAMED06950900961748 EUDAMED06950900941009 EUDAMED06942033969197 EUDAMED06950900903847 EUDAMED06950900941085 EUDAMED06950900940941 EUDAMED06950900941313 EUDAMED06942033969210 EUDAMED06950900961939 EUDAMED06950900999666 EUDAMED06950900906145 EUDAMED06950900941047 EUDAMED06950900903793 EUDAMED06950900924514 EUDAMED06942033969142 EUDAMED06950900903762 EUDAMED06950900903854 EUDAMED06942033937547 EUDAMED06950900961915 EUDAMED06950900941030 EUDAMED06950900906534 EUDAMED06950900940842 EUDAMED06950900999765 EUDAMED06950900903816 EUDAMED06950900999680 EUDAMED06950900961946 EUDAMED06950900981463 EUDAMED06950900961786 EUDAMED06950900920585 EUDAMED06950900905100 EUDAMED06950900999802 EUDAMED06950900922343 EUDAMED06950900933073 EUDAMED06950900923029 EUDAMED06950900926013 EUDAMED06950900999703 EUDAMED06950900940897 EUDAMED06950900999772 EUDAMED06950900940859 EUDAMED06942033969098 EUDAMED06942033969067 EUDAMED06942033969241 EUDAMED06942033969050 EUDAMED06950900961793 EUDAMED06942033969234 EUDAMED06950900926808 EUDAMED06950900940811 EUDAMED06950900903755 EUDAMED06950900923524 EUDAMED06950900981449 EUDAMED06942033969074 EUDAMED06950900999871 EUDAMED06942033969203 EUDAMED06950900999741 EUDAMED06950900903878 EUDAMED06950900903922 EUDAMED06950900941337 EUDAMED06942033969180 EUDAMED06950900903786 EUDAMED06950900903885 EUDAMED06950900940972 EUDAMED06950900999710 EUDAMED06950900999673 EUDAMED06950900906480 EUDAMED06950900940996 EUDAMED06950900940965 EUDAMED06950900940934 EUDAMED06950900941115 EUDAMED06942033969135 EUDAMED06950900941122 EUDAMED06950900903984 EUDAMED06950900906466 EUDAMED06950900941054 EUDAMED06950900999734 EUDAMED06950900903953 EUDAMED06950900941023 EUDAMED06950900906497 EUDAMED06942033937516 EUDAMED06950900940873 EUDAMED06950900923357 EUDAMED06950900903861 EUDAMED06950900923500 EUDAMED06942033976775 EUDAMED06950900930249 EUDAMED
- Basic UDI-DI
- 69509009CEIKRW EUDAMED
- 510(k) Number
- K180178 FDA UDI
- FDA Product Code
- DYB FDA UDI
- EMDN Code
- C0504 ARTERIAL INTRODUCTION SETS EUDAMED
- GMDN Term
- Interventional radiology percutaneous-access kit, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1340 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Interventional radiology percutaneous-access kit, single-use
Introducer Set by Shanghai INT Medical Instruments Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Interventional radiology percutaneous-access kit, single-use.
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- EXTesia — Curatia Medical Limited · Class IIa
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- PMI — PROGRESSIVE MEDICAL, INC. · Class II
- EXTesia — Curatia Medical Limited · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69509009CEIKRW | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Shanghai INT Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000009966
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (152)
- EUDAMED e21ff6af-1462-4b2a-a2d6-7b321d0f6d8a 61 fields · synced Sep 30, 2026
- FDA UDI 3bd3aa44-91ec-4578-a44b-b503f6f54570 33 fields · synced May 24, 2026
- FDA UDI 531ac620-8d5b-4b1f-9d27-fa3b9e331e7a 33 fields · synced May 25, 2026
- FDA UDI d52673a0-abe2-4318-8b56-00ddf5d925bf 33 fields · synced May 27, 2026
- FDA UDI bca1bf41-b657-4c14-a1fd-5b2fdc97f909 33 fields · synced May 29, 2026
- FDA UDI fc56d83b-5e5d-4107-8f51-d5311afe7cda 33 fields · synced May 29, 2026
- FDA UDI 0a394223-a5b6-41e2-9e87-05cb30385681 33 fields · synced May 29, 2026
- FDA UDI f5882489-7882-4e07-942b-57690ab19007 33 fields · synced May 29, 2026
- FDA UDI 495a168c-1c1f-4d4e-af86-0f71d66cc324 33 fields · synced May 29, 2026
- FDA UDI ec86930b-27eb-4a82-ab81-2efea9ef9f7d 33 fields · synced May 29, 2026
- FDA UDI 93b6ae35-1354-4b0b-a4f8-0d6a2c82044d 33 fields · synced May 29, 2026
- FDA UDI bae13daa-4740-40b2-8aae-6260feff6ee4 33 fields · synced May 30, 2026
- FDA UDI 2e8eda37-88be-47de-bb76-bd7ef81b858d 33 fields · synced May 30, 2026
- FDA UDI 6177f46a-8c14-4130-aa72-65373da3b9cb 33 fields · synced May 30, 2026
- FDA UDI adf49b8a-4912-4680-8e36-8f300b344070 33 fields · synced May 30, 2026
- FDA UDI 1fd6aeea-9923-401a-b06d-22ae3b879f1c 33 fields · synced May 30, 2026
- FDA UDI a2eda45c-b32f-46f7-8cb2-7055f71b97fb 33 fields · synced May 30, 2026
- FDA UDI e19a2f42-9ae7-463e-9542-703c4eb2686d 33 fields · synced May 30, 2026
- FDA UDI 0bed437e-b2f5-4de6-b7ec-c1f3da979bdf 33 fields · synced May 30, 2026
- FDA UDI 6eb04112-70c0-4e53-8840-7583daa5c9db 33 fields · synced May 30, 2026
- FDA UDI 60a6a258-42ee-477d-8b28-81968d17bed7 33 fields · synced May 30, 2026
- FDA UDI 1a81f76a-d5c9-4e6d-bddc-91854e876a0e 33 fields · synced May 30, 2026
- FDA UDI 0dabdfc0-45c7-4aef-bddd-af4b5203d6a9 33 fields · synced May 30, 2026
- FDA UDI 5fb0974c-b27e-40b5-b713-5ed0abb97ab6 33 fields · synced May 30, 2026
- FDA UDI 9bb4ac63-4642-4735-810b-02ffaf808b03 33 fields · synced May 30, 2026
- FDA UDI 26c08423-756d-4df4-ae14-b1abc3b3d7d9 33 fields · synced May 30, 2026
- FDA UDI d0af3047-f7cf-4ec7-88b2-e3e42b5c3ed1 33 fields · synced May 30, 2026
- FDA UDI 1f39aa29-9864-49a5-8bae-539586141440 33 fields · synced May 30, 2026
- EUDAMED ff470ced-e858-408c-8c7a-c4eaff44cf34 61 fields · synced Jun 18, 2026
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- EUDAMED 2cb776d6-f84f-48fa-a194-b3ae394c9f8b 61 fields · synced Jun 20, 2026
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- EUDAMED b419edc7-a305-4d95-8384-88de2056b91a 61 fields · synced Jul 9, 2026
- EUDAMED 7747b0b7-7efa-41db-8bdc-028af1f92fdd 61 fields · synced Jul 9, 2026
- EUDAMED 4ec32a4b-450b-4055-936b-0b430ac16d84 61 fields · synced Jul 10, 2026
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- EUDAMED 2f7a1da8-733b-4917-8097-a1b92478643d 61 fields · synced Jul 10, 2026
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- EUDAMED 19dea77f-5f0f-41eb-a067-5cc217f8e9c1 61 fields · synced Jul 12, 2026
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- EUDAMED 98470d94-29e2-4115-8d49-6079c0467c63 61 fields · synced Jul 13, 2026
- EUDAMED 0364d252-64a4-4ff3-8392-f3430f813b46 61 fields · synced Jul 13, 2026
- EUDAMED d81ad342-6cb6-436d-9395-f7010955ebd1 61 fields · synced Jul 13, 2026
- EUDAMED 39ed7467-d026-4d16-bdd3-8501841590c0 61 fields · synced Jul 13, 2026
- EUDAMED 38485159-1563-4f69-bab4-2f844af32530 61 fields · synced Jul 13, 2026
- EUDAMED a4cf1a25-6a39-48a7-a937-0d4057e4c9b9 61 fields · synced Jul 14, 2026
- EUDAMED be92ae61-91bd-4161-b2dc-8ca86871031e 61 fields · synced Jul 14, 2026
- EUDAMED d0066665-0d03-4e5a-8b97-7a7ce4de02ba 61 fields · synced Jul 14, 2026
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- EUDAMED 97ece08c-34cf-4185-82ce-219607c08ed2 61 fields · synced Jul 15, 2026
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- EUDAMED 4a906dbd-f5b7-4ef2-a698-3a69252d36c3 61 fields · synced Jul 15, 2026
- EUDAMED 55037726-1094-45c9-bc46-7049558b96da 61 fields · synced Jul 16, 2026
- EUDAMED 721b2883-b010-4e44-b084-ca1dfd618a20 61 fields · synced Jul 16, 2026
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- EUDAMED b485c12c-c824-48dc-9d25-ef3f48e7380f 61 fields · synced Jul 16, 2026
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- EUDAMED 47e5701b-d128-41fb-a32d-0ff5722a5ca1 61 fields · synced Jul 17, 2026
- EUDAMED 9bd253be-a1b3-424c-800a-b932d77e2783 61 fields · synced Jul 18, 2026
- EUDAMED 1a49a660-9c91-460e-824e-5a1e736621d7 61 fields · synced Jul 19, 2026
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