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EXEL Catheter Tip Syringe, 50mL

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 26304

by Exelint International, Co.

Identity

Trade Name
EXEL Catheter Tip Syringe, 50mL EUDAMED
EXEL 50-60ml SYR ONLY CATH.TIP, W/ CAP FDA UDI
Generic Name
General-purpose syringe, single-use FDA UDI
Device Name
EXEL Catheter Tip Syringe EUDAMED
EXEL 50-60ml SYR ONLY CATH.TIP, W/ CAP FDA UDI
Model / Reference
26304 EUDAMEDFDA UDI
Description
EXEL 50-60ml SYR ONLY CATH.TIP, W/ CAP FDA UDI

Identifiers

Primary DI / UDI-DI
00020221263046 EUDAMEDFDA UDI
Basic UDI-DI
20221CATHTIP263BU EUDAMED
510(k) Number
K861153 FDA UDI
FDA Product Code
FMF FDA UDI
EMDN Code
A02010203 INFUSION AND IRRIGATION SYRINGES, CATHETER CONE, SINGLE-USE EUDAMED
GMDN Term
General-purpose syringe, single-use FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
880.5860 FDA UDI
Market of Registration
Germany 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

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

EXEL Catheter Tip Syringe, 50mL by Exelint International, Co. — Class I — 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
Exelint International, Co.
EUDAMED SRN
US-MF-000037396
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (2)

  • EUDAMED 5c3d4965-d3a0-41c6-bab1-3bce49eb5953 61 fields · synced Jun 18, 2026
  • FDA UDI e7872bcd-e797-40d9-acc1-492451e56f3b 34 fields · synced May 29, 2026