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Sterile Oral Syringes for single use
EUDAMEDFDA 510(k)Class I (EU MDR)
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Identity
- Device Name
- Sterile Oral Syringes for single use EUDAMED
- Model / Reference
- OASC3ML EUDAMEDOASC1ML EUDAMEDOASC5ML EUDAMEDOASC10ML EUDAMEDOSC20ML EUDAMEDOSC3ML EUDAMEDOASC20ML EUDAMEDOSC5ML EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16930197870777 EUDAMED16930197870760 EUDAMED16930197870784 EUDAMED16930197870791 EUDAMED16930197870753 EUDAMED16930197870722 EUDAMED16930197870807 EUDAMED16930197870739 EUDAMED
- Basic UDI-DI
- 6930197820211ms07502D2 EUDAMED6930197820211ms07501CY EUDAMED
- EMDN Code
- A020108 ENTERAL FEEDING SYRINGES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sterile Oral Syringes for single use by Shanghai Kindly Enterprise Development Group Co., Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K223678 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 6930197820211ms07502D2 | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000005652
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (9)
- EUDAMED 44cab141-ff6d-4c88-8e4d-9d65f4c4486b 61 fields · synced Jul 27, 2026
- EUDAMED 5b8f37a2-ea68-449e-ae08-ce8545c6eaeb 61 fields · synced May 16, 2026
- EUDAMED c672981e-bb5b-48b1-8a89-701d0bbfc582 61 fields · synced May 16, 2026
- EUDAMED 9975c951-7968-4f9d-a41b-55dc3822f333 61 fields · synced May 18, 2026
- EUDAMED c8f07077-c3d0-477e-bc93-eaea5294e39f 61 fields · synced May 18, 2026
- EUDAMED 037a8fd5-8875-43fe-9b35-fe7d4f517509 61 fields · synced May 18, 2026
- EUDAMED b7f34517-0502-4336-847d-2f016ab016a3 61 fields · synced May 18, 2026
- EUDAMED de68e1d8-284b-4dc8-a342-6982c41eed9f 61 fields · synced May 18, 2026
- FDA 510(k) K223678 1 fields · synced May 18, 2026