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Ifak 2

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 3331061

by FareTec Inc

Identity

Trade Name
IFAK 2 EUDAMED
IFAK FDA UDI
Generic Name
First aid kit, non-medicated, single-use FDA UDI
Device Name
Individual First-Aid Kit (IFAK) EUDAMED
IFAK Kit 2 FDA UDI
Model / Reference
3331061 EUDAMED
IFAK Kit 2 FDA UDI
Description
IFAK Kit 2 FDA UDI

Identifiers

Catalog Number
3331061 FDA UDI
Primary DI / UDI-DI
B54133310610 EUDAMEDFDA UDI
Basic UDI-DI
++B5413333WQ EUDAMED
FDA Product Code
OHO FDA UDI
EMDN Code
V0501 CLINICAL EMERGENCY KITS EUDAMED
GMDN Term
First aid kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
878.4014 FDA UDI
Medical Purpose
Individual First-Aid Kit (IFAK) is a procedure pack which contain devices intended for the first aid support to the individual. EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Ifak 2 by Faretec, Inc. — 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
FareTec Inc
EUDAMED SRN
US-PR-000013441

Sources (2)

  • EUDAMED 3218b9f7-31fb-42e9-9de8-22b534320755 61 fields · synced Jun 19, 2026
  • FDA UDI e91b0b19-4ae8-451b-a9d4-5ca5598d71af 35 fields · synced May 30, 2026