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Oci-16g(25)
EUDAMEDClass IIa (EU MDR)
Ref 06937909306169Model OCI-14GRef OCI-16G
Identity
- Trade Name
- OCI-16G(25) EUDAMEDOCI EUDAMED
- Device Name
- Arteriovenous Fistula Needle Sets EUDAMED
- Model / Reference
- OCI-14G EUDAMED06937909306169 EUDAMEDOCI-16G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937909306169 EUDAMED
- Basic UDI-DI
- 69379093AFNS001U6 EUDAMEDB-06937909306169 EUDAMED
- EMDN Code
- F020102 ARTERIOVENOUS DIALYSIS LINES, TWO NEEDLES EUDAMEDA010401 ARTERIOVENOUS FISTULA NEEDLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMEDGreece 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
Oci-16g(25) by Chengdu Oci Medical Devices Co., Ltd. — Class IIa — CE/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 | 69379093AFNS001U6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Chengdu Oci Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000009700
- Authorised Representative
- Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551
Sources (2)
- EUDAMED f015bbc2-169d-480e-83c1-855d76ee0c7d 61 fields · synced Oct 6, 2026
- EUDAMED 1ccc2621-21da-4f35-afa6-99a79a009f48 61 fields · synced Jul 17, 2026