Y connector Pack

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref YCK112AModel YCK, MNYCK, HV-1~HV-9Ref YCK111Model YCK111,YCK111a~YCK111f,YCK113,YCK113a~YCK113x,YCK118a,Y CK118b,YCK118d,YCK119a~YCK119dRef HV-40TSRef HV-5M0PRef HV-9MTSRef HV-7MT0Ref HV-8MTSRef HV-7000Ref HV-2000Ref HV-90TSRef HV-10T0Ref HV-4MTSRef HV-400PRef HV-9MT0Ref YCK100ARef HV-6M0PRef YCK115CRef YCK118IRef YCK112BRef HV-7M0PRef HV-8MTPRef HV-900PRef HV-4M00Ref HV-5000Ref YCK100GRef HV-300SRef HV-70TSRef HV-5MT0Ref YCK119BRef HV-90TPRef HV-400SRef HV-800PRef HV-7M0SRef HV-3MT0Ref HV-5M0SRef HV-3M00Ref HV-2M00Ref YCK100DRef HV-9MTPRef YCK100BRef HV-4MT0Ref HV-70TPRef HV-8MT0Ref HV-5MTSRef HV-800SRef HV-700PRef HV-600PRef HV-40T0Ref HV-2MTPRef HV-30TSRef HV-70T0Ref HV-9000Ref HV-8M0SRef HV-6000Ref YCK115DRef HV-2MT0Ref HV-6M0SRef YCK100CRef YCK111CRef YCK113SRef YCK115ARef YCK100IRef HV-30T0Ref HV-2M0SRef HV-700SRef HV-500PRef HV-30TPRef HV-4M0SRef HV-3M0SRef HV-50TPRef HV-3MTPRef HV-3MTSRef HV-80T0Ref YCK118DRef HV-1M00Ref HV-8M0PRef HV-9M0PRef HV-60TPRef YCK118A

by Shanghai INT Medical Instruments Co., Ltd.

Identity

Trade Name: Y connector Pack EUDAMED
INT FDA UDI
Generic Name: Vascular guidewire introduction sleeve FDA UDI
Device Name: Y connector Pack EUDAMED
Push-click type Y connector; FDA UDI
Push-pull Y connector with 15 cm extension tube,45 psi stopcock, torque device, insertion tool; FDA UDI
Push-pull Y connector with 50 cm extension tube,45 psi stopcock; FDA UDI
Screw type Y connector FDA UDI
Screw type Y connector,torque device(copper core), insertion tool; FDA UDI
Push-Rotate Y connector, torque device, insertion tool; FDA UDI
Push-click Y connector with 25 cm extension tube,45 psi stopcock; FDA UDI
Push-pull type Y connector; FDA UDI
Screw type Y connector with 25 cm extension tube, 45 psi stopcock; FDA UDI
Push-click Y connector, torque device, insertion tool; FDA UDI
Model / Reference: YCK, MNYCK, HV-1~HV-9 EUDAMED
YCK112A EUDAMEDFDA UDI
YCK111,YCK111a~YCK111f,YCK113,YCK113a~YCK113x,YCK118a,Y CK118b,YCK118d,YCK119a~YCK119d EUDAMED
YCK111 EUDAMED
YCK100B EUDAMEDFDA UDI
YCK118A EUDAMEDFDA UDI
YCK100I EUDAMEDFDA UDI
YCK111C EUDAMEDFDA UDI
YCK100C EUDAMEDFDA UDI
YCK100D EUDAMEDFDA UDI
YCK100A EUDAMEDFDA UDI
YCK112B EUDAMEDFDA UDI
YCK119B EUDAMEDFDA UDI
HV-40TS EUDAMED
HV-5M0P EUDAMED
HV-9MTS EUDAMED
HV-7MT0 EUDAMED
HV-8MTS EUDAMED
HV-7000 EUDAMED
HV-2000 EUDAMED
HV-90TS EUDAMED
HV-10T0 EUDAMED
HV-4MTS EUDAMED
HV-400P EUDAMED
HV-9MT0 EUDAMED
HV-6M0P EUDAMED
YCK115C EUDAMED
YCK118I EUDAMED
HV-7M0P EUDAMED
HV-8MTP EUDAMED
HV-900P EUDAMED
HV-4M00 EUDAMED
HV-5000 EUDAMED
YCK100G EUDAMED
HV-300S EUDAMED
HV-70TS EUDAMED
HV-5MT0 EUDAMED
HV-90TP EUDAMED
HV-400S EUDAMED
HV-800P EUDAMED
HV-7M0S EUDAMED
HV-3MT0 EUDAMED
HV-5M0S EUDAMED
HV-3M00 EUDAMED
HV-2M00 EUDAMED
HV-9MTP EUDAMED
HV-4MT0 EUDAMED
HV-70TP EUDAMED
HV-8MT0 EUDAMED
HV-5MTS EUDAMED
HV-800S EUDAMED
HV-700P EUDAMED
HV-600P EUDAMED
HV-40T0 EUDAMED
HV-2MTP EUDAMED
HV-30TS EUDAMED
HV-70T0 EUDAMED
HV-9000 EUDAMED
HV-8M0S EUDAMED
HV-6000 EUDAMED
YCK115D EUDAMED
HV-2MT0 EUDAMED
HV-6M0S EUDAMED
YCK113S EUDAMED
YCK115A EUDAMED
HV-30T0 EUDAMED
HV-2M0S EUDAMED
HV-700S EUDAMED
HV-500P EUDAMED
HV-30TP EUDAMED
HV-4M0S EUDAMED
HV-3M0S EUDAMED
HV-50TP EUDAMED
HV-3MTP EUDAMED
HV-3MTS EUDAMED
HV-80T0 EUDAMED
YCK118D EUDAMED
HV-1M00 EUDAMED
HV-8M0P EUDAMED
HV-9M0P EUDAMED
HV-60TP EUDAMED
Description: Push-click type Y connector; FDA UDI
Push-pull Y connector with 15 cm extension tube,45 psi stopcock, torque device, insertion tool; FDA UDI
Push-pull Y connector with 50 cm extension tube,45 psi stopcock; FDA UDI
Screw type Y connector FDA UDI
Screw type Y connector,torque device(copper core), insertion tool; FDA UDI
Push-Rotate Y connector, torque device, insertion tool; FDA UDI
Push-click Y connector with 25 cm extension tube,45 psi stopcock; FDA UDI
Push-pull type Y connector; FDA UDI
Screw type Y connector with 25 cm extension tube, 45 psi stopcock; FDA UDI
Push-click Y connector, torque device, insertion tool; FDA UDI

Identifiers

Primary DI / UDI-DI: 06950900922220 EUDAMEDFDA UDI
D-YConnectorPackBN EUDAMED
06950900941399 EUDAMEDFDA UDI
06950900923401 EUDAMEDFDA UDI
06950900906657 EUDAMEDFDA UDI
06950900929403 EUDAMEDFDA UDI
06950900965302 EUDAMEDFDA UDI
06950900906626 EUDAMEDFDA UDI
06950900922060 EUDAMEDFDA UDI
06950900906671 EUDAMEDFDA UDI
06950900922350 EUDAMEDFDA UDI
06942033933112 EUDAMED
06942033933181 EUDAMED
06942033933686 EUDAMED
06942033932740 EUDAMED
06942033933570 EUDAMED
06942033933365 EUDAMED
06942033932818 EUDAMED
06942033933662 EUDAMED
06942033932801 EUDAMED
06942033933136 EUDAMED
06942033933044 EUDAMED
06942033932764 EUDAMED
06942033933297 EUDAMED
06950900957413 EUDAMED
06942033968589 EUDAMED
06942033933402 EUDAMED
06942033933563 EUDAMED
06942033933594 EUDAMED
06942033933068 EUDAMED
06942033933143 EUDAMED
06950900906008 EUDAMED
06942033932948 EUDAMED
06942033933440 EUDAMED
06942033932726 EUDAMED
06942033933655 EUDAMED
06942033933051 EUDAMED
06942033933488 EUDAMED
06942033933419 EUDAMED
06942033932702 EUDAMED
06942033933198 EUDAMED
06942033932955 EUDAMED
06942033932849 EUDAMED
06942033933679 EUDAMED
06942033932719 EUDAMED
06942033933433 EUDAMED
06942033932757 EUDAMED
06942033933242 EUDAMED
06942033933495 EUDAMED
06942033933372 EUDAMED
06942033933266 EUDAMED
06942033933099 EUDAMED
06942033932900 EUDAMED
06942033933006 EUDAMED
06942033933426 EUDAMED
06942033933587 EUDAMED
06942033933525 EUDAMED
06942033933259 EUDAMED
06950900960543 EUDAMED
06942033932696 EUDAMED
06942033933303 EUDAMED
06942033968602 EUDAMED
06950900952579 EUDAMED
06942033932986 EUDAMED
06942033932863 EUDAMED
06942033933389 EUDAMED
06942033933150 EUDAMED
06942033932993 EUDAMED
06942033933082 EUDAMED
06942033932979 EUDAMED
06942033933211 EUDAMED
06942033933013 EUDAMED
06942033933020 EUDAMED
06942033933532 EUDAMED
06942033968565 EUDAMED
06942033932795 EUDAMED
06942033933518 EUDAMED
06942033933624 EUDAMED
06942033933327 EUDAMED
Basic UDI-DI: 69509009CEYCKQA EUDAMED
B-YConnectorPackBN EUDAMED
510(k) Number: K170024 FDA UDI
FDA Product Code: DTL FDA UDI
EMDN Code: C010480 ANGIOGRAPHY AND HEMODYNAMICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
GMDN Term: Vascular guidewire introduction sleeve FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 870.4290 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

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Vascular guidewire introduction sleeve

Y connector Pack by Shanghai INT Medical Instruments Co., Ltd. — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

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Also classified as Vascular guidewire introduction sleeve.

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

European Union Active

CE/MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	69509009CEYCKQA	Class IIa	Active
EUDAMED	European Union	CE/MDR	69509009CEYCKQA	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 (89)

EUDAMED 7962dd0e-d0db-46c7-887c-993325b3d60c 61 fields · synced Sep 17, 2026
EUDAMED af31fd02-6f82-46ff-9010-f46b2b09282a 61 fields · synced May 17, 2026
FDA UDI 2e312854-01a7-4085-93a9-d12ffd0e1342 34 fields · synced May 24, 2026
FDA UDI fc136e8f-8a84-4162-a0e8-d442a9ca174b 34 fields · synced May 25, 2026
FDA UDI 0913a3e0-7b42-4ff7-997b-f82012cb43f2 34 fields · synced May 29, 2026
FDA UDI ddd3ceac-e7af-4671-a716-c43751e8795f 34 fields · synced May 30, 2026
FDA UDI e048224a-8a65-4907-8a36-4a93795b1db8 34 fields · synced May 30, 2026
FDA UDI 86528d76-4bd6-4549-bed7-40bad4b0702e 34 fields · synced May 30, 2026
FDA UDI 90e3a548-f0da-4dd1-be31-ebec69732611 34 fields · synced May 30, 2026
FDA UDI 68b0c5d3-9282-47df-888b-37380d776b68 34 fields · synced May 30, 2026
FDA UDI 716dad42-f77e-462b-8eef-f5513f640834 34 fields · synced May 30, 2026
FDA UDI 6d18383e-06b6-43fb-a929-88db75fabb9e 34 fields · synced May 30, 2026
EUDAMED 5f82d78c-e367-4885-95a6-1242801acbed 61 fields · synced Jun 14, 2026
EUDAMED 061d5675-06af-49b6-8375-68cd2085d29d 61 fields · synced Jun 20, 2026
EUDAMED 74bac138-594f-4996-8535-7b56f8461cf5 61 fields · synced Jul 8, 2026
EUDAMED bb0388e1-af16-4402-8645-5e2ecf3751db 61 fields · synced Jul 9, 2026
EUDAMED 9cd171aa-7cd8-4514-b3ae-dd2f3fb4fa6f 61 fields · synced Jul 9, 2026
EUDAMED ee1746ac-a658-427c-96a0-1515768bdbcb 61 fields · synced Jul 9, 2026
EUDAMED b5628479-ac8b-4cdc-8c13-55c91b9466ab 61 fields · synced Jul 9, 2026
EUDAMED fd9811d4-9066-4eac-8575-f53201463558 61 fields · synced Jul 9, 2026
EUDAMED 7451bda1-8f17-46e4-8901-feee097e4fd1 61 fields · synced Jul 9, 2026
EUDAMED 21365d01-522e-4833-ad81-5e5d74261cb6 61 fields · synced Jul 9, 2026
EUDAMED 5226cb38-0782-4604-ba5a-86117dffdeaf 61 fields · synced Jul 9, 2026
EUDAMED f1da6c78-b522-470b-8d96-1f2cc4bfc2a2 61 fields · synced Jul 9, 2026
EUDAMED c9fc5d94-0bbb-42cf-ae7d-c2e910ff09f3 61 fields · synced Jul 10, 2026
EUDAMED 97450d90-471b-4a72-ab2e-064a9d02fe5f 61 fields · synced Jul 10, 2026
EUDAMED 0a402f4c-4758-4c99-8335-e7d550dd07b1 61 fields · synced Jul 10, 2026
EUDAMED 0d64a4ab-1ac0-4c97-bcb2-359d895fe059 61 fields · synced Jul 10, 2026
EUDAMED b8ee105e-fbb6-428e-ab24-0992c1ab2ac1 61 fields · synced Jul 10, 2026
EUDAMED 37cbb332-cf83-43f0-86c3-96f51c71dd31 61 fields · synced Jul 10, 2026
EUDAMED 02121c01-1f3d-4142-8a56-ac5586d2cca0 61 fields · synced Jul 10, 2026
EUDAMED 81fa37ec-dea5-4e0d-a55a-eda73457b8c8 61 fields · synced Jul 10, 2026
EUDAMED d04178aa-56bf-47eb-aa43-d0eed50ee9cc 61 fields · synced Jul 10, 2026
EUDAMED 05801129-aa3f-42e2-a4ba-0184d87f1feb 61 fields · synced Jul 11, 2026
EUDAMED 1de45d73-4a8b-479d-a354-80b2a9b36bdc 61 fields · synced Jul 11, 2026
EUDAMED c712e90b-e589-4b8c-8801-085ce20c27c7 61 fields · synced Jul 11, 2026
EUDAMED c554d9d6-a7ee-4491-bf2c-8d477f1ce5d6 61 fields · synced Jul 13, 2026
EUDAMED 12771bc8-8772-4dd6-8eee-dbb998cc632a 61 fields · synced Jul 13, 2026
EUDAMED 69a3f2ce-4aba-4bb1-a27b-a5dd69c8aa2b 61 fields · synced Jul 13, 2026
EUDAMED 8badbbd1-2653-49a1-a38d-81eae121e501 61 fields · synced Jul 14, 2026
EUDAMED 342a1dbf-5b32-43b6-9aae-06650953b630 61 fields · synced Jul 14, 2026
EUDAMED 58fcd707-d311-42fc-a5da-bbcfe9fad84c 61 fields · synced Jul 15, 2026
EUDAMED 697da011-a221-4c06-a6bb-4bd0f110c14e 61 fields · synced Jul 15, 2026
EUDAMED 06572c15-d6d8-47b5-bc78-43a2f712a973 61 fields · synced Jul 15, 2026
EUDAMED d3569d21-90aa-4559-916a-00f31db7910a 61 fields · synced Jul 15, 2026
EUDAMED cd7250ab-7492-4e0e-8c78-80dd0891ca37 61 fields · synced Jul 16, 2026
EUDAMED 020bb5be-1c06-4711-bc27-25a891b31be2 61 fields · synced Jul 16, 2026
EUDAMED aa25380c-40db-4c7a-b260-86b8520560b8 61 fields · synced Jul 17, 2026
EUDAMED 555427bf-0588-460a-a762-98dff7f383d0 61 fields · synced Jul 17, 2026
EUDAMED 8975a1a0-98ad-4016-b4d5-d42c3af0a357 61 fields · synced Jul 17, 2026
EUDAMED 791cb8b1-3c15-405d-9407-b0e986564225 61 fields · synced Jul 18, 2026
EUDAMED ae53dd9f-cf1b-4266-aa1a-aff7a38d2ea5 61 fields · synced Jul 19, 2026
EUDAMED f8b67d91-30fb-4e37-a65e-f12f7adcf5f4 61 fields · synced Jul 19, 2026
EUDAMED c83dd267-3eae-481c-9008-1c391fe50389 61 fields · synced Jul 19, 2026
EUDAMED 4139e542-019f-4123-aefa-9a059083399a 61 fields · synced Jul 19, 2026
EUDAMED f94d13d3-a2ae-4f15-9ad0-18ccac211df0 61 fields · synced Jul 20, 2026
EUDAMED 1eb6c2e7-2aaa-4a35-950e-04cc1cbc495d 61 fields · synced Jul 20, 2026
EUDAMED 355bced1-3de8-4594-a5f8-e790e76437e7 61 fields · synced Jul 20, 2026
EUDAMED 9e031549-42ac-408f-a336-b58a0b324c5c 61 fields · synced Jul 21, 2026
EUDAMED c947a801-f5f6-4d1b-a9ee-33f68459e0a5 61 fields · synced Jul 21, 2026
EUDAMED 79ef8b67-43ae-4daa-93f6-2778cbc9d9e5 61 fields · synced Jul 21, 2026
EUDAMED c5c9b793-58fd-4654-9ed6-525e9bd8a7c7 61 fields · synced Jul 22, 2026
EUDAMED 4e39eaa4-2356-454e-a85d-3ffce563faed 61 fields · synced Jul 22, 2026
EUDAMED f29e05f5-1971-4e21-a9a0-af43ba00096c 61 fields · synced Jul 22, 2026
EUDAMED fa1ffacd-04d1-483f-b061-3354296d1ea4 61 fields · synced Jul 22, 2026
EUDAMED d7752ff7-9dac-483f-a771-44235a71f790 61 fields · synced Jul 22, 2026
EUDAMED 4cd7c1e0-185f-4d98-a3a3-d0b05a98caa3 61 fields · synced Jul 23, 2026
EUDAMED 121eb1b6-b34c-44ee-8faf-93aa712e636f 61 fields · synced Jul 24, 2026
EUDAMED 7b34c286-2b5b-4266-9281-cc15887f65fe 61 fields · synced Jul 25, 2026
EUDAMED 87f9f8f6-d1a8-4379-8afa-2b19cf140b67 61 fields · synced Jul 26, 2026
EUDAMED 91239a6b-4f78-4c83-9cb7-3a8cc804b1c8 61 fields · synced Jul 26, 2026
EUDAMED 81c783e8-f389-4d78-8c76-cf8c6957f6a5 61 fields · synced Jul 26, 2026
EUDAMED 33c1ab73-34dc-4b42-836d-27bf227c664f 61 fields · synced Jul 26, 2026
EUDAMED 7d5cb4a7-0112-4db9-9f3a-4baeda9705d6 61 fields · synced Jul 27, 2026
EUDAMED 19508bb7-e30d-4d23-803f-fb94812476c5 61 fields · synced Jul 27, 2026
EUDAMED c4f382ee-de88-40b0-91e5-4b1ebda7a2bd 61 fields · synced Jul 28, 2026
EUDAMED 8922e5a2-b14c-46bc-895b-46bdda6f5b6d 61 fields · synced Jul 29, 2026
EUDAMED d63abc41-b517-48b7-a87b-faa7fb6799f7 61 fields · synced Jul 29, 2026
EUDAMED 0517f81a-f608-4a5b-99a0-eed6905f5e20 61 fields · synced Jul 29, 2026
EUDAMED 8f1aaa54-29dc-4f9e-b9b8-b78d0c9413c3 61 fields · synced Jul 30, 2026
EUDAMED fc35bf7e-9d09-4cd1-ae72-372649742f4b 61 fields · synced Jul 31, 2026
EUDAMED b66140db-6ad1-453c-a3eb-ec63f463521d 61 fields · synced Aug 1, 2026
EUDAMED e4c97f98-e06b-487f-b9ef-f0bbf10996b4 61 fields · synced Aug 1, 2026
EUDAMED ceccc91d-0373-4beb-80ce-3eaf99d35d84 61 fields · synced Aug 2, 2026
EUDAMED 5e0c472f-9156-4750-97fb-75bcf8b1c788 61 fields · synced Aug 2, 2026
EUDAMED 5271bb2c-cf6d-490d-b27c-f7c1b24d67aa 61 fields · synced Aug 3, 2026
EUDAMED 251839bd-fb03-41ee-8bb1-08dc40949515 61 fields · synced Aug 3, 2026
EUDAMED 002eb340-b75c-4e6c-8c06-077a4e9f4731 61 fields · synced Aug 4, 2026
EUDAMED 5157cf03-f9a0-49d6-af0c-505764767352 61 fields · synced Sep 17, 2026