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SPENCER ITALIA SRL

www.spencer.it

✓ Record-verifiedregistrations found in 8 marketsEU SRN IT-MF-000027507

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Taiwan, Australia, Russia — 8 overseas markets. EU UDI-DI records ≥299, 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

≥299UDI-DI device records

Class I 244Class IIa 55

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

9listed device types

Class I 9Class II 0Class III 0

plus 9 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

11registered device records

Class I 11

BRBrazilANVISA

11registered devices

Class I 11

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

98registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

6valid device licences

Class I 6

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

9active ARTG entries

Class I 9

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

6active registrations

Class 1 4Class 2a 2

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 Union576 raw hits, 1 excluded, 299 confirmed. Large result set — only the first 300 verified

United States9 registration records, 0 510(k), 0 PMA, 5 excluded

United Kingdom11 confirmed, 1 excluded

Brazil11 confirmed, 1 excluded

Saudi Arabia98 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: SPENCER ITALIA SRL · SPENCER ITÁLIA SRL · Spencer Italia Srl · Spencer Italia s.r.l · Spencer Italia S.r.l. · Spencer Italia s.r.l.

Regulatory identity

EU manufacturer SRN: IT-MF-000027507
UK responsible person: Maclin Power Ltd
Exhibition record: CMEF 93rd (Apr 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

FDA listed device types

showing 8 of 9

Stretcher, Hand-Carried 1Orthosis, Lumbar 1Orthosis, Truncal/Orthosis, Limb 1Splint, Extremity, Non-Inflatable, External, Non-Sterile 1Orthosis, Cervical 1Stretcher, Patient Restraint 1Device, Transfer, Patient, Manual 1Catheters, Suction, Tracheobronchial 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08057711238712	RES-Q-BOARD - TAVOLA RESUSC.ARANCIO	Class I
EU	08057711238705	MOD.K003 CARRERA S TEC 68 T/GIALLO P/NERO C/QMX777	Class I
EU	08057711238606	MOD.M011 ASPIRATORE PULSEVAC C/VASO 1000R	Class IIa
EU	08057711238590	MOD.M011 ASPIRATORE PULSEVAC C/VASO SERRES	Class IIa
UK	41630	406 SPENCER AMBULANCE CARRYING CHAIR CHROMED PLATE	Class I
UK	45129	NEC UP ADULT - MULTI-SIZE COLLAR	Class I
UK	63273	AIR SPLINT - INFLATABLE SPLINT FOR ARM 37 CM	Class I
BR	80888720034	DISPOSITIVO DE EXTRAÇÃO SPENCER	Class I
BR	80888720025	Maca à vácuo	Class I
BR	80888720003	IMOBILIZADOR DE CABEÇA	Class I
SA	ME0000008945SFDAA00001	Super blue head immobilizer	—
SA	ME0000008945SFDAA00002	Urra splint	—

SPENCER ITALIA SRL

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA listed device types

Registration details (sample)

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