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Gbuk
EUDAMEDClass IIa (EU MDR)
Ref IVDISCAP-10-EUModel FRef NFC0-STPCK14-EXPModel Stopcock Neutral with Extension LineRef BCN-2025Model PN-1Ref SBCWN-H-2319-20-AUTOModel button with holderRef BCSN-2138Model SPN-1Ref BCSN-H-2232Model SPN-1hRef BCSN-2132Ref SBCWN-H-2519-30-AUTORef BCSN-2225Ref SBCWN-H-2119-30-AUTORef SBCWN-2319-20-AUTOModel button without holderRef NFC0-S-EXPModel P series with needle-freeRef BC022175Model 21G*3/4*12"Ref BCH-WIDEModel thread connector wide neckRef NFC0-D-EXPModel with needle-freeRef NFC0-Q-ARV-EXPModel Quad Lumen with Anti Reflux Valve Neutral Extension SetRef BCH+LA-WIDEModel luer male connector wide neckRef BCN-2232Ref PFS-10SSModel 10mLRef SBCWN-2119-20-AUTORef BCN-2132Ref SBCWN-2519-30-AUTORef SBCWN-H-2519-20-AUTORef BCN-2225Ref SBCWN-H-2119-20-AUTORef PFS-5SSModel 5mLRef BCN-2325Ref BCSN-2125Ref BCSN-H-2132Ref BCN-2332Ref BCH+LLModel luer male connectorRef PFS-10DSModel PP02 series
Identity
- Trade Name
- GBUK EUDAMEDCAINA EUDAMED
- Device Name
- Needlefree Disinfection Cap EUDAMEDIntravenous extension sets w/o accessories EUDAMEDBlood Collection Needle EUDAMEDSafelock Disposable Blood Collection Sets EUDAMEDSafety Blood Collection Needles EUDAMEDDisposable Safelock Blood Collection Sets EUDAMEDBlood Collection Holder Wide EUDAMEDAccess Device-holder with Sample Adapter EUDAMEDPre-filled Syringe with Saline EUDAMEDAccess Device- holder with Sample Adapter EUDAMED
- Model / Reference
- F EUDAMEDIVDISCAP-10-EU EUDAMEDStopcock Neutral with Extension Line EUDAMEDNFC0-STPCK14-EXP EUDAMEDPN-1 EUDAMEDBCN-2025 EUDAMEDbutton with holder EUDAMEDSBCWN-H-2319-20-AUTO EUDAMEDSPN-1 EUDAMEDBCSN-2138 EUDAMEDSPN-1h EUDAMEDBCSN-H-2232 EUDAMEDBCSN-2132 EUDAMEDSBCWN-H-2519-30-AUTO EUDAMEDBCSN-2225 EUDAMEDSBCWN-H-2119-30-AUTO EUDAMEDbutton without holder EUDAMEDSBCWN-2319-20-AUTO EUDAMEDP series with needle-free EUDAMEDNFC0-S-EXP EUDAMED21G*3/4*12" EUDAMEDBC022175 EUDAMEDthread connector wide neck EUDAMEDBCH-WIDE EUDAMEDwith needle-free EUDAMEDNFC0-D-EXP EUDAMEDQuad Lumen with Anti Reflux Valve Neutral Extension Set EUDAMEDNFC0-Q-ARV-EXP EUDAMEDluer male connector wide neck EUDAMEDBCH+LA-WIDE EUDAMEDBCN-2232 EUDAMED10mL EUDAMEDPFS-10SS EUDAMEDSBCWN-2119-20-AUTO EUDAMEDBCN-2132 EUDAMEDSBCWN-2519-30-AUTO EUDAMEDSBCWN-H-2519-20-AUTO EUDAMEDBCN-2225 EUDAMEDSBCWN-H-2119-20-AUTO EUDAMED5mL EUDAMEDPFS-5SS EUDAMEDBCN-2325 EUDAMEDBCSN-2125 EUDAMEDBCSN-H-2132 EUDAMEDBCN-2332 EUDAMEDluer male connector EUDAMEDBCH+LL EUDAMEDPP02 series EUDAMEDPFS-10DS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971564462112 EUDAMED06971564461368 EUDAMED06971564463775 EUDAMED06971564465502 EUDAMED06971564463935 EUDAMED06971564463973 EUDAMED06971564463911 EUDAMED06971564465830 EUDAMED06971564463904 EUDAMED06971564465540 EUDAMED06971564461771 EUDAMED06971564461375 EUDAMED06971564466714 EUDAMED16971564464007 EUDAMED06971564461382 EUDAMED06971564461436 EUDAMED06971564464048 EUDAMED06971564463836 EUDAMED06971564461092 EUDAMED06971564460835 EUDAMED06971564463829 EUDAMED06971564465366 EUDAMED06971564465519 EUDAMED06971564463799 EUDAMED06971564465397 EUDAMED06971564461085 EUDAMED06971564463805 EUDAMED06971564463898 EUDAMED06971564463966 EUDAMED06971564463843 EUDAMED06971564464024 EUDAMED06971564462969 EUDAMED
- Basic UDI-DI
- B-06971564462112 EUDAMED6971564460030B2M EUDAMED69715644600230ZL EUDAMED69715644600401ZP EUDAMED697156446004802G EUDAMED697156446004812J EUDAMED69715644600400ZM EUDAMED69715644600300ZG EUDAMEDB-06971564466714 EUDAMED6971564460032523 EUDAMED69715644600303ZN EUDAMED6971564460030A2K EUDAMED69715644600321ZQ EUDAMEDB-06971564461092 EUDAMEDB-06971564461085 EUDAMED69715644600320ZN EUDAMED69715644600341ZW EUDAMED
- EMDN Code
- D0702 ISOPROPYL ALCOHOL FOR THE DISINFECTION OF MEDICAL DEVICES EUDAMEDA03020101 LOW PRESSURE EXTENSION LINES EUDAMEDA01010502 NEEDLES FOR COLLECTION UNDER VACUUM, W/O SAFETY SYSTEMS EUDAMEDA01010501 NEEDLES FOR COLLECTION UNDER VACUUM, WITH SAFETY SYSTEMS EUDAMEDA03020102 HIGH PRESSURE EXTENSION LINES EUDAMEDA01018001 HOLDERS FOR COLLECTION NEEDLES EUDAMEDA02010701 PREFILLED SYRINGES WITH STERILE PHYSIOLOGICAL SOLUTION EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMED
- Market of Registration
- Austria EUDAMEDGermany EUDAMEDNetherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMED
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
Gbuk by Jiangsu Caina Medical Co., Ltd. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06971564462112 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | B-06971564462112 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Jiangsu Caina Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000011217
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (32)
- EUDAMED 01bc3d50-5716-46c6-8f48-b5b8b97490dd 61 fields · synced Oct 6, 2026
- EUDAMED b97128a1-7000-4665-8ea0-0b1563333b0c 61 fields · synced May 16, 2026
- EUDAMED f4f787ad-c2c4-483f-874b-2ed416a19c74 61 fields · synced May 16, 2026
- EUDAMED ae799cc2-4724-4c2d-a70a-52699173dfdb 61 fields · synced May 16, 2026
- EUDAMED a2f953e8-81f4-42b5-bd51-91675d256026 61 fields · synced May 16, 2026
- EUDAMED 985979be-13fa-424f-a784-d0ead9a5bbf5 61 fields · synced May 16, 2026
- EUDAMED 9b3140ea-d660-45de-8d45-e4bb14a6ed74 61 fields · synced May 17, 2026
- EUDAMED 78e4d0c0-17d7-46c1-89f1-49a83da41bb9 61 fields · synced May 17, 2026
- EUDAMED 11cd2e97-bc54-489a-af7a-92a3c6430a03 61 fields · synced May 17, 2026
- EUDAMED 12211b63-d2a2-4507-82f1-361cc6473093 61 fields · synced May 17, 2026
- EUDAMED 9febafe7-0c5a-48ac-852c-1445e8f6d532 61 fields · synced May 17, 2026
- EUDAMED 802b1a77-07c3-4e8b-9440-466ec1725661 61 fields · synced May 17, 2026
- EUDAMED 8275879c-4234-4e6e-bc3a-f75f70e98c2e 61 fields · synced May 17, 2026
- EUDAMED 551b8419-f86d-4b2b-bb43-52052748e460 61 fields · synced May 17, 2026
- EUDAMED 9a2ab86d-b9b3-464b-bab7-e82a15e62264 61 fields · synced May 17, 2026
- EUDAMED 15840574-4c59-4805-b591-afba0fd2be15 61 fields · synced May 17, 2026
- EUDAMED adde1aca-08db-4b0c-b953-b5d068e2ad72 61 fields · synced May 17, 2026
- EUDAMED 7adc26e1-0d0c-49ce-89a6-1dbf1559b7b4 61 fields · synced May 17, 2026
- EUDAMED c6b9ca4e-2fc8-4021-b344-3d7ebb411eda 61 fields · synced May 18, 2026
- EUDAMED 9298ec34-14d3-41bc-94c2-d16bf002150d 61 fields · synced May 18, 2026
- EUDAMED a4abd9b7-c053-4380-9430-56ecf5a1054d 61 fields · synced May 18, 2026
- EUDAMED d837fdb4-d51c-48ec-b8aa-6d47dac0fccd 61 fields · synced May 18, 2026
- EUDAMED e287f9a0-e351-4ec3-992c-8b63869d16f7 61 fields · synced May 18, 2026
- EUDAMED ea274c49-25e6-4126-9440-b4199b4d05cc 61 fields · synced May 18, 2026
- EUDAMED 8b24986c-b601-4c7f-99eb-68fd3d11008f 61 fields · synced May 18, 2026
- EUDAMED cf298c48-46ce-425f-968e-b6d3f7d36ee5 61 fields · synced May 18, 2026
- EUDAMED 9173e03d-f962-4425-b7c6-71493cf5d91c 61 fields · synced May 18, 2026
- EUDAMED e3aa7777-1084-46d1-ac9f-2f9c6960f4f1 61 fields · synced May 18, 2026
- EUDAMED 558ccc98-f38b-4876-a30f-ab42436fc2e0 61 fields · synced May 18, 2026
- EUDAMED 6aff4891-3d0e-4008-99f9-fb39475b8960 61 fields · synced May 19, 2026
- EUDAMED a9b4c8d3-3004-4b3f-be88-deda9321ac8c 61 fields · synced May 19, 2026
- EUDAMED bf125f99-7536-44ff-a62c-949309073f37 61 fields · synced May 19, 2026