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Kosen

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 125003Model M-03

by Tianck Medical Co., Ltd.

Identity

Trade Name
Kosen EUDAMED
Manifold FDA UDI
Generic Name
Infusion line manifold FDA UDI
Device Name
Manifold EUDAMED
Right on 500PSI FDA UDI
Model / Reference
M-03 EUDAMEDFDA UDI
125003 EUDAMED
Description
Right on 500PSI FDA UDI

Identifiers

Catalog Number
125003 FDA UDI
Primary DI / UDI-DI
06936841203987 EUDAMED
06971162817246 FDA UDI
Basic UDI-DI
697116281MF12FF EUDAMED
FDA Product Code
DTL FDA UDI
EMDN Code
A0799 ADAPTERS, CONNECTORS, RAMPS, STOPCOCKS, CAPS - OTHER EUDAMED
GMDN Term
Infusion line manifold FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
870.4290 FDA UDI
Market of Registration
Türkiye EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

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

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Kosen by Tianck Medical Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tianck Medical Co., Ltd.
EUDAMED SRN
CN-MF-000007451
Authorised Representative
Lotus NL B.V. NL-AR-000000121

Sources (2)

  • EUDAMED e1d4a120-de09-4907-b672-b454b701bd6a 61 fields · synced Oct 6, 2026
  • FDA UDI ce6d27ab-2009-4202-9e54-345b1ac92eda 34 fields · synced May 30, 2026