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ABX Pentra Glucose HK CP

EUDAMEDFDA UDIFDA 510(k)

Class C (EU MDR)

Ref A11A01667

by Horiba Abx Sas

Identity

Trade Name
ABX Pentra Glucose HK CP EUDAMEDFDA UDI
Generic Name
Glucose IVD, kit, spectrophotometry FDA UDI
Device Name
ABX Pentra Glucose HK CP EUDAMED
Model / Reference
A11A01667 EUDAMED
1220001667 FDA UDI

Identifiers

Primary DI / UDI-DI
03610230005200 EUDAMEDFDA UDI
Basic UDI-DI
361023pentra_glu_hkJ3 EUDAMED
510(k) Number
K052007 FDA UDI
FDA Product Code
CFR FDA UDI
EMDN Code
W01010213 GLUCOSE EUDAMED
GMDN Term
Glucose IVD, kit, spectrophotometry FDA UDI

Classification

Device Class
Class C EUDAMED
Class II FDA UDI
Regulation Number
862.1345 FDA UDI
Market of Registration
France 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

No

EUDAMED

Animal Tissues

Yes

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

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

ABX Pentra Glucose HK CP by Horiba Abx Sas — Class C — FDA_510K, IVDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
Horiba Abx Sas
EUDAMED SRN
FR-MF-000000320

Sources (3)

  • EUDAMED f0d57a41-afb9-4051-980d-8321f8e4693c 61 fields · synced Jul 27, 2026
  • FDA UDI 058f530b-7abd-4287-97b4-c9fd66fc07b3 33 fields · synced May 30, 2026
  • FDA 510(k) K081276 1 fields · synced Jun 9, 2026