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Exel Hypo Ndl 20g X 2"

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 26460

by Exelint International, Co.

Identity

Trade Name
EXEL HYPO NDL 20G X 2" EUDAMED
EXEL HYPO NDL 20G X 2" FDA UDI
Generic Name
Hypodermic needle, single-use FDA UDI
Device Name
Hypodermic Needle EUDAMED
EXEL HYPO NDL 20G X 2" 100/BX, 2000/CS, 5CS/CRTN FDA UDI
Model / Reference
26460 EUDAMEDFDA UDI
Description
EXEL HYPO NDL 20G X 2" 100/BX, 2000/CS, 5CS/CRTN FDA UDI

Identifiers

Catalog Number
26460 FDA UDI
Primary DI / UDI-DI
00020221264609 EUDAMEDFDA UDI
Basic UDI-DI
B-00020221264609 EUDAMED
510(k) Number
K861153 FDA UDI
FDA Product Code
FMF FDA UDI
EMDN Code
A0101010102 HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS EUDAMED
GMDN Term
Hypodermic needle, single-use 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 Hypo Ndl 20g X 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 508606e1-b540-4578-83b4-f85ea203c713 61 fields · synced Jun 17, 2026
  • FDA UDI bd1ec49d-8b9b-4433-952a-f17cdb5e7efe 36 fields · synced May 30, 2026