HomeWELDON INSTRUMENTS

WELDON INSTRUMENTS

www.weldoninstruments.com
✓ Record-verifiedregistrations found in 4 marketsEU SRN PK-MF-000010180

This company has registrations in European Union, United States, United Kingdom, Brazil — 4 overseas markets. EU UDI-DI records ≥300, 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
≥300UDI-DI device records
Class IIa 300
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
33listed device types
Class I 33Class II 0Class III 0
plus 33 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
100registered device records
Class I 96Class IIa 4
BRBrazilANVISA
21registered devices
Class I 19Class II 2
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
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
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 Union3,340 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified
United States33 registration records, 0 510(k), 0 PMA
United Kingdom100 confirmed, 0 excluded
Brazil21 confirmed, 1 excluded
Manufacturer names merged into this page: Weldon Instruments · WELDON INSTRUMENTS

Regulatory identity

EU manufacturer SRN
PK-MF-000010180
EU authorised representative
CMC Medical Devices & Drugs SL
UK responsible person
Spire Instrumentation Ltd
Exhibition record
CMEF 89th (Apr 2024, Shanghai)

Company information

Employees
100–500
Annual revenue
under RMB 5M
Company type
Manufacturer
Website
www.weldoninstruments.com

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.

FDA listed device types

showing 8 of 33
Dilator, Catheter 1Forceps 1Trocar, Tracheal 1Hook, Bone 1Probe 1Evacuator, Oral Cavity 1Rasp 1Scissors, Orthopedic, Surgical 1

Registration details (sample)

MarketIdentifierNameClass / date
EU05056863311666WS-633-112N: Non-Sterile, Single Use, Müller Micro Tweezers Jeweler Style, 11cm/4¾”, Ring Ø 1.2 mm, Class IIa
EU05056863311659WS-633-111N: Non-Sterile, Single Use, Müller Micro Tweezers Jeweler Style, 11cm/4¾”, 1x2 TeethClass IIa
EU05056863311642WS-633-110N: Non-Sterile, Single Use, Müller Micro Tweezers Jeweler Style, 11cm/4¾”, 0.3 mm, Class IIa
EU05056863311635WS-633-109N: Non-Sterile, Single Use, Müller Micro Tweezers Jeweler Style, 11cm/4¾”, 0.2 mm, Class IIa
UK31264Airway tube forceps, reusableClass I
UK35131Amputation knifeClass I
UK13481Bandage scissors, reusableClass I
BR10150470439Instrumentais Não Articulados Cortantes WeldonClass I
BR10150470441Instrumentais Cirúrgicos Articulados Cortantes WeldonClass I
BR10150470448Instrumentais Articulados Não Cortantes WeldonClass I

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