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EXEL U-40 1mL INS SYR 29GX1/2"

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 26037

by Exelint International, Co.

Identity

Trade Name
EXEL U-40 1mL INS SYR 29GX1/2" EUDAMEDFDA UDI
Generic Name
Insulin syringe/needle, basic FDA UDI
Device Name
Insulin Syringe EUDAMED
EXEL U-40 1mL INS SYR 29GX1/2", 10/BAG, 100/BX, 500/CS, 6CS/CRTN FDA UDI
Model / Reference
26037 EUDAMEDFDA UDI
Description
EXEL U-40 1mL INS SYR 29GX1/2", 10/BAG, 100/BX, 500/CS, 6CS/CRTN FDA UDI

Identifiers

Catalog Number
26037 FDA UDI
Primary DI / UDI-DI
00020221260373 EUDAMEDFDA UDI
Basic UDI-DI
B-00020221260373 EUDAMED
510(k) Number
K861153 FDA UDI
FDA Product Code
FMF FDA UDI
EMDN Code
A02010601 INSULIN SYRINGES WITH FIXED NEEDLE, SINGLE-USE EUDAMED
GMDN Term
Insulin syringe/needle, basic FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
880.5860 FDA UDI
Market of Registration
Netherlands 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

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

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

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 U-40 1mL INS SYR 29GX1/2" by Exelint International, Co. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

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 27b55926-ab70-4c3e-af42-456702b99688 61 fields · synced Jul 16, 2026
  • FDA UDI 5c85f5f9-5cd6-4776-9ca1-73af0dfd6885 36 fields · synced May 30, 2026