BIOCINCH-AI2

Identification

Model: Nonabsorbable Soft Tissue & Bone Fixation Device - Meniscal Repair Devices
EMDN: H9007, P09120102
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: Yes
Measuring function: No
Reusable surgical: No

Certificates

2024-MDR/TD-034

EU technical documentation assessment · valid

Notified body: 3EC International a.s. (2265)

Valid from 2024-01-07 · Expiry 2029-01-07

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

2024-MDR/QS-034

EU quality management system · valid

Notified body: 3EC International a.s. (2265)

Valid from 2024-07-01 · Expiry 2029-07-01

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

SRN IN-MF-000013541

IN · Ahmedabad, Gujarat

manufacturer

Authorised representative: CMC Medical Devices & Drugs SL (ES-AR-000000293)

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