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Mozec™ PTA 0.035" OTW

EUDAMED

Class IIa (EU MDR)

Ref MO35030040AModel Usable length 800 mm

by Meril Life Sciences Pvt. Ltd.

Identity

Trade Name
Mozec™ PTA 0.035" OTW EUDAMED
Device Name
Mozec™ PTA 0.035" OTW Balloon Dilatation Catheter EUDAMED
Model / Reference
Usable length 800 mm EUDAMED
MO35030040A EUDAMED

Identifiers

Primary DI / UDI-DI
18904224901633 EUDAMED
Basic UDI-DI
B-18904224901633 EUDAMED
EMDN Code
C010401020101 PTCA BALLOON DILATION CATHETERS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Türkiye EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

Yes

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Coronary angioplasty balloon catheter, cutting/scoring

Mozec™ PTA 0.035" OTW by Meril Life Sciences Pvt. Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Coronary angioplasty balloon catheter, cutting/scoring.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

EUDAMED SRN
IN-MF-000008308
Authorised Representative
Obelis s.a. BE-AR-000000106

Sources (1)

  • EUDAMED f3ab9d61-847f-4ad5-8fba-e6c5ae9e7043 61 fields · synced Jul 15, 2026