← Back to catalogue
Oci-14g(32)
EUDAMEDClass IIa (EU MDR)
Ref 06937909306411Model OCI-14GRef 06937909306145
Identity
- Trade Name
- OCI-14G(32) EUDAMEDOCI-14G(25) EUDAMEDOCI EUDAMED
- Device Name
- Arteriovenous Fistula Needle Sets EUDAMED
- Model / Reference
- OCI-14G EUDAMED06937909306411 EUDAMED06937909306145 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937909306411 EUDAMED06937909306145 EUDAMED
- Basic UDI-DI
- 69379093AFNS001U6 EUDAMEDB-06937909306411 EUDAMEDB-06937909306145 EUDAMED
- EMDN Code
- A010401 ARTERIOVENOUS FISTULA NEEDLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass IIb 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-14g(32) 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 |
Is this your device? Claim it to add documentation and request validation.
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 (4)
- EUDAMED cf6fd20c-f766-4e32-8c03-234bd2538df7 61 fields · synced Oct 6, 2026
- EUDAMED f3695dbb-048d-4fc6-afbd-5c036913a397 61 fields · synced May 19, 2026
- EUDAMED a72d8b16-d59d-4e7b-a621-dd5424be06a0 61 fields · synced Jul 16, 2026
- EUDAMED 369c1fb7-0d8c-49fd-944c-cf6fcfbcfff4 61 fields · synced Oct 5, 2026