HomeGermanyFUJIFILM Wako Chemicals Europe GmbH

FUJIFILM Wako Chemicals Europe GmbH

Germany · Neuss · www.wako-chemicals.de
✓ Record-verifiedregistrations found in 9 marketsEU SRN JP-MF-000010401

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Singapore, Australia, Hong Kong, Russia — 9 overseas markets. EU UDI-DI records ≥203, the first 300 verified individually. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
≥203UDI-DI device records
Class I 36Class IIa 97Class IIb 10IVD A 9IVD general 51
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
12listed device types
Class I 5Class II 7Class III 0
plus 11 registration records and 124 510(k)
UKUnited KingdomMHRA PARD
209registered device records
Class I 47Class IIa 73Class IIb 14IVD A 10IVD B 18IVD C 2IVD general 43System or Procedure Pack 2
BRBrazilANVISA
10registered devices
Class II 10
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
14active device licences
Class II 14
25 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
2device registrations
CLASS C 2
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
3active ARTG entries
IVD Class 2 3
HKHong KongMDACS
4valid listings
IVD C 4
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
1active registrations
Class 1 1
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union1,693 raw hits, 97 excluded, 203 confirmed. Large result set — only the first 300 verified
United States11 registration records, 124 510(k), 0 PMA, 2 excluded
United Kingdom209 confirmed, 6 excluded
Brazil10 confirmed, 0 excluded
Canada14 confirmed, 0 excluded
Manufacturer names merged into this page: FUJIFILM Wako Pure Chemical Corporation Diagnostics Design Office (Amagasaki) · FUJIFILM WAKO PURE CHEMICAL CORPORATION · FUJIFILM WAKO CHEMICALS U.S.A. CORPORATION
Same-named companies — This database also contains companies with near-identical names: Wako Pure Chemical Industries, Ltd.. Company name alone cannot separate their registrations, so the figures below may include either.

Regulatory identity

EU manufacturer SRN
JP-MF-000010401
EU authorised representative
FUJIFILM Healthcare Europe GmbH
UK responsible person
Fujifilm Healthcare UK Limited

Company information

Country
Germany
City
Neuss
Website
www.wako-chemicals.de
Product categories
Clinical Diagnostics & Therapeutic TechnologiesLaboratory, IVD & DiagnosticsClinical chemistry & immunoassays

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Legal name
FUJIFILM Wako Chemicals Europe Gesellschaft mit beschränkter Haftung
LEI
529900KT4UG7ZTRH3456
Registration status
Active
Legal form
Gesellschaft mit beschränkter Haftung (GmbH)
Incorporated
1974-05-27
Registration authority
Commercial Register, no. HRB 3935
Registry record updated
2026-02-12

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

261987
121988
21989
21990
11991
41992
51995
31996
41997
11998
91999
142000
52001
12002
42003
62004
32005
22007
22008
12011

FDA listed device types

showing 8 of 12
Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) 1System, Test, Low Density, Lipoprotein 1Titrimetric, Fatty Acids 1Ldl & Vldl Precipitation, Hdl 1Single (Specified) Analyte Controls (Assayed And Unassayed) 1Micro Total Analysis Instrument System 1Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma 1Calibrator, Secondary 1

Registration details (sample)

MarketIdentifierNameClass / date
EU04573596214015ARIETTA 750LEClass IIa
EU04573596214039ARIETTA 750VEClass IIa
EU04573596214022ARIETTA 750SEClass IIa
EU04547410542530FCR PROFECT CS PlusClass IIa
UK52924FUJI DRI-CHEM SLIDE GPT/ALT-P IIIIVD general
UK59071FUJI DRI-CHEM SLIDE ALB-PIVD general
UK53207FUJI DRI-CHEM CONTROL QNIVD general
USK100464UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION2011-02-23
USK080125APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-252012008-07-18
USK080123APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-252012008-07-17
BR80022060099PYROSTAR™ ES-F Controle Padrão de EndotoxinasClass II
BR80022060100PYROSTAR™ ES-F Água Reagente LALClass II
BR80022060097PYROSTAR™ ES-F Lisado BulkClass II
CA65894AUTOKIT APO A1 (APOLIPOPROTEIN)Class II
CA65895AUTOKIT MICRO TP (TOTAL PROTEIN)Class II
CA65896AUTOKIT APO B (APOLIPOPROTEIN)Class II

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