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AST Medical
EUDAMEDClass I (EU MDR)
Ref EN025LModel O-ring Type clearRef EN0210Ref TM18079L20Model NARef EN0260Ref EN023LRef BC07WAModel luer male connector wide neckRef EN0120Model with ENFit connector,clearRef BC02232010 Model lock with holderRef EN0220Ref EN0160Ref EN0110Ref EN015LRef EN021LRef TM18079L05
Identity
- Trade Name
- AST Medical EUDAMED
- Device Name
- Reusable O-ring gasket syringe with ENFit connector EUDAMEDDisposable Neuraxial Fit Tip Syringes EUDAMEDAccess Device-holder with Sample Adapter EUDAMEDSERINGUE EUDAMEDSafelock Disposable Blood Collection Sets with Holder EUDAMED
- Model / Reference
- O-ring Type clear EUDAMEDEN025L EUDAMEDEN0210 EUDAMEDNA EUDAMEDTM18079L20 EUDAMEDEN0260 EUDAMEDEN023L EUDAMEDluer male connector wide neck EUDAMEDBC07WA EUDAMEDwith ENFit connector,clear EUDAMEDEN0120 EUDAMEDlock with holder EUDAMEDBC02232010 EUDAMEDEN0220 EUDAMEDEN0160 EUDAMEDEN0110 EUDAMEDEN015L EUDAMEDEN021L EUDAMEDTM18079L05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971564464215 EUDAMED06971564464116 EUDAMED06971564469524 EUDAMED06971564464130 EUDAMED06971564464208 EUDAMED06971564464536 EUDAMED06971564468282 EUDAMED06971564469548 EUDAMED06971564464123 EUDAMED06971564464222 EUDAMED06971564463027 EUDAMED06971564463010 EUDAMED06971564464529 EUDAMED06971564469500 EUDAMED
- Basic UDI-DI
- 6971564460008424 EUDAMED69715644600100Z6 EUDAMED69715644600321ZQ EUDAMED69715644600080ZR EUDAMED697156446003912G EUDAMED
- EMDN Code
- A020108 ENTERAL FEEDING SYRINGES EUDAMEDA020102020102 INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE EUDAMEDA01018001 HOLDERS FOR COLLECTION NEEDLES EUDAMEDA01010501 NEEDLES FOR COLLECTION UNDER VACUUM, WITH SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMED
- Market of Registration
- Austria 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
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
AST Medical by Jiangsu Caina Medical Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6971564460008424 | Class I | 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 (14)
- EUDAMED d6f94c8a-53e4-4995-be00-e21997cc5c69 61 fields · synced Oct 6, 2026
- EUDAMED e869d7e1-8c20-4695-baad-0d8f32dbd0f0 61 fields · synced May 11, 2026
- EUDAMED 04f0fb83-d48a-4874-b521-007cedf6d566 61 fields · synced May 16, 2026
- EUDAMED 21f7421b-8458-4f43-901c-130fadc87141 61 fields · synced May 16, 2026
- EUDAMED 8b2e0e19-03c5-4272-a49b-941500350400 61 fields · synced May 17, 2026
- EUDAMED 0b97c74f-74eb-401b-9422-9e04ab613022 61 fields · synced May 17, 2026
- EUDAMED 48f35334-4d32-4146-a005-c98b4a435360 61 fields · synced May 17, 2026
- EUDAMED 00dbfa4a-966d-4974-a565-fc29ac3c8b1d 61 fields · synced May 17, 2026
- EUDAMED f26d5772-a1b2-4af2-9ed3-ab9643ee5272 61 fields · synced May 18, 2026
- EUDAMED 2446dee7-22c7-4e4e-9e24-291af71027e4 61 fields · synced May 18, 2026
- EUDAMED f214f5fc-e077-4fe4-9c1a-f03fc8aaebed 61 fields · synced May 18, 2026
- EUDAMED 35418d2c-adec-4f94-a260-8c6b1f2e059b 61 fields · synced May 18, 2026
- EUDAMED 54c9ae40-b688-42a7-9f19-b24e0055a102 61 fields · synced May 19, 2026
- EUDAMED 89d4f7e2-f700-40a1-a67c-13e76c544f9e 61 fields · synced May 19, 2026