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EXEL Hypodermic Needle 22G x 1-1/2"

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 26412Ref 26436

by Exelint International, Co.

Identity

Trade Name
EXEL Hypodermic Needle 22G x 1-1/2" EUDAMED
EXEL HYPO NDL 22G X 1-1/2 EUDAMED
EXEL HYPO NDL 22G X 1/2", EUDAMED
EXEL Hypodermic Needle 22G x 1/2" EUDAMED
EXEL HYPO NDL 22GX1/2" FDA UDI
Generic Name
Hypodermic needle, single-use FDA UDI
Device Name
EXEL Hypodermic Needle EUDAMED
Hypodermic Needle EUDAMED
EXEL HYPO NDL 22GX1/2", 100/BX, 2000/CS, 5CS/CRTN FDA UDI
Model / Reference
26412 EUDAMED
26436 EUDAMEDFDA UDI
Description
EXEL HYPO NDL 22GX1/2", 100/BX, 2000/CS, 5CS/CRTN FDA UDI

Identifiers

Catalog Number
26436 FDA UDI
Primary DI / UDI-DI
00020221264128 EUDAMED
00020221264364 EUDAMEDFDA UDI
Basic UDI-DI
20221HYPONDL264VZ EUDAMED
B-00020221264128 EUDAMED
B-00020221264364 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
Austria EUDAMED
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

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

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 Hypodermic Needle 22G x 1-1/2" by Exelint International, Co. — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

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 (5)

  • EUDAMED f511e336-f2b7-4772-a9aa-97165e6a2dd2 61 fields · synced Oct 6, 2026
  • EUDAMED eac32c6a-0f2c-4899-9b13-5e926f33f77d 61 fields · synced May 18, 2026
  • EUDAMED ae24b422-c2a4-47db-b29a-1a4878de09c3 61 fields · synced May 19, 2026
  • FDA UDI 60874a17-f9e2-4a42-8e54-3d0f3dceb481 36 fields · synced May 30, 2026
  • EUDAMED ca211c06-65cc-4eed-9180-835ddfccaae0 61 fields · synced Jul 17, 2026