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Apolipoprotein Control - Level 3 (apo Control 3)

EUDAMEDFDA UDI

Class B (EU MDR)

Ref LE5018

by Randox Laboratories Limited

Identity

Trade Name
APOLIPOPROTEIN CONTROL - LEVEL 3 (APO CONTROL 3) EUDAMED
APOLIPOPROTEIN CONTROL - LEVEL 3 (APO CONTROL 3) FDA UDI
Generic Name
Multiple apolipoprotein IVD, control FDA UDI
Device Name
APOLIPOPROTEIN CONTROL EUDAMED
Model / Reference
LE5018 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
05055273209129 EUDAMEDFDA UDI
Basic UDI-DI
50552732BAPOCON016EE EUDAMED
FDA Product Code
JJY FDA UDI
EMDN Code
W0102152003 SPECIFIC PROTEIN CONTROLS EUDAMED
GMDN Term
Multiple apolipoprotein IVD, control FDA UDI

Classification

Device Class
Class B EUDAMED
Class I FDA UDI
Regulation Number
862.1660 FDA UDI
Market of Registration
Northern Ireland 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

Human Tissues

Yes

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

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

No

FDA UDI

Apolipoprotein Control - Level 3 (apo Control 3) by Randox Laboratories Limited — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Randox Laboratories Limited
EUDAMED SRN
XI-MF-000028410

Sources (2)

  • EUDAMED a2f8212d-58d8-4e8f-b3cb-bd8252af084f 61 fields · synced Jul 16, 2026
  • FDA UDI 4de2f62e-5ba3-4fe3-a7c9-ad567658215d 32 fields · synced May 30, 2026