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Apci-8050

EUDAMEDFDA UDI

Class IVD General (EU MDR)

Ref 225-19601-55

by Shimadzu Corporation

Identity

Trade Name
APCI-8050 EUDAMED
APCI-8050 SET FDA UDI
Generic Name
Mass spectrometry analyser IVD FDA UDI
Device Name
Liquid Chromatograph Mass Spectrometer EUDAMED
Model / Reference
225-19601-55 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
04540217400713 EUDAMEDFDA UDI
Basic UDI-DI
B-04540217400713 EUDAMED
FDA Product Code
DOP FDA UDI
EMDN Code
W020303 MASS - SPECTROMETRY SYSTEM EUDAMED
GMDN Term
Mass spectrometry analyser IVD FDA UDI

Classification

Device Class
Class IVD General EUDAMED
Class I FDA UDI
Regulation Number
862.2860 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

Yes

EUDAMED

Prescription Use

Yes

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Apci-8050 by Shimadzu Corporation — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shimadzu Corporation
EUDAMED SRN
JP-MF-000025145
Authorised Representative
Shimadzu Europa GmbH DE-AR-000013563

Sources (2)

  • EUDAMED 35d6bc14-d776-498a-857f-ea92b5f91f50 61 fields · synced Jul 14, 2026
  • FDA UDI e058c497-a1c0-42d7-8357-3a8349c355dc 32 fields · synced May 30, 2026