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EXEL Disposable Syringe with Needle, 1mL Luer Slip Tip W/ 27G x 1/2"

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref 26040Ref 26044

by Exelint International, Co.

Identity

Trade Name
EXEL Disposable Syringe with Needle, 1mL Luer Slip Tip W/ 27G x 1/2" EUDAMED
EXEL Disposable Syringe with Needle, 1mL Luer Slip Tip W/ 25G x 5/8" EUDAMED
EXEL Syringes FDA UDI
Generic Name
General-purpose syringe, single-use FDA UDI
Device Name
EXEL Disposable Syringe with Needle EUDAMED
Syringe, 1CC, Luer Slip, 25G x 5/8 FDA UDI
Syringe, 1CC, Luer Slip, 27G X 1/2 FDA UDI
Model / Reference
26040 EUDAMEDFDA UDI
26044 EUDAMEDFDA UDI
Description
Syringe, 1CC, Luer Slip, 25G x 5/8 FDA UDI
Syringe, 1CC, Luer Slip, 27G X 1/2 FDA UDI

Identifiers

Catalog Number
26044 FDA UDI
26040 FDA UDI
Primary DI / UDI-DI
00020221260403 EUDAMEDFDA UDI
00020221260441 EUDAMEDFDA UDI
Basic UDI-DI
20221SYRNDL261PG EUDAMED
FDA Product Code
FMF FDA UDI
EMDN Code
A020102010201 INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITH NEEDLE, SINGLE-USE EUDAMED
GMDN Term
General-purpose syringe, single-use FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
880.5860 FDA UDI
Market of Registration
Austria EUDAMED
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 Disposable Syringe with Needle, 1mL Luer Slip Tip W/ 27G x 1/2" by Exelint International, Co. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID…

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Exelint International, Co.
EUDAMED SRN
US-MF-000037396
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (5)

  • EUDAMED f3de781a-50f2-4725-8fbe-70774683b814 61 fields · synced Oct 6, 2026
  • FDA UDI 82e7fa12-4e83-46dd-a231-66495b89435c 34 fields · synced May 30, 2026
  • FDA UDI fbd02218-cb0a-4993-aca9-97a104e4293e 34 fields · synced May 30, 2026
  • EUDAMED 86af71a4-0bfd-4367-9f7a-69df7dbfeacb 61 fields · synced Jul 23, 2026
  • FDA 510(k) K251089 1 fields · synced May 18, 2026