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PRINCE MEDICAL SAS

France · Ercuis · www.prince-medical.com

✓ Record-verifiedregistrations found in 9 marketsEU SRN FR-MF-000009486

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, South Korea, Australia, Israel — 9 overseas markets. EU UDI-DI records ≥8, 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

≥8UDI-DI device records

Class IIa 8

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

USUnited StatesFDA openFDA

6listed device types

Class I 2Class II 3Class III 1

plus 7 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

36registered device records

Class I 26Class IIa 9Class IIb 1

BRBrazilANVISA

18registered devices

Class I 8Class 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

9active device licences

Class II 9

TWTaiwanTFDA

3valid device licences

Class I 2Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 3

AUAustraliaTGA ARTG

13active ARTG entries

Class I 1IIa 4IIb 1Class Is (sterile) 7

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

14registrations

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 Union326 raw hits, 292 excluded, 8 confirmed. Large result set — only the first 300 verified

United States7 registration records, 1 510(k), 0 PMA, 2 excluded

United Kingdom36 confirmed, 6 excluded

Brazil18 confirmed, 0 excluded

Canada9 confirmed, 0 excluded

Manufacturer names merged into this page: PRINCE MEDICAL SAS · PRINCE MEDICAL

Regulatory identity

EU manufacturer SRN: FR-MF-000009486
UK responsible person: FLEXELEC UK LTD

Business registration

Legal name: PRINCE MEDICAL
SIREN: 391442381
Registration status: Active
Legal form: Société par actions simplifiée (SAS)
Incorporated: 1993-06-01
Principal activity: Fabrication de matériel médico-chirurgical et dentaire (32.50A)
Employee size band: 20–49
Registered address: ZA DE LA SENTE DU MOULIN 60530 ERCUIS

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

FDA 510(k) clearances by year

11998 · K981855

FDA listed device types

Device, Cystometric, Hydraulic 1Endoscopic Ultrasound System, Gastroenterology-Urology 1Cystometric Gas (Carbon-Dioxide) On Hydraulic Device 1Evacuator, Bladder, Manually Operated 1Retractor 1Implant, Intragastric For Morbid Obesity 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	03665039000406	ENDOLINE®2V-JECT	Class IIa
EU	03665039021210	NASO-KIT	Class IIa
EU	03665039021197	NASO-KIT	Class IIa
EU	03665039021173	NASO-KIT	Class IIa
UK	45846	INTRA?UTERINE?CATHETER	Class I
UK	10696	NASOBILIARY?PROBE	Class IIa
UK	47070	HISTOLOGICAL?SAMPLING?PROBE	Class I
US	K981855	PRINCE MEDICAL CEMENT PLUG	1998-08-10
BR	10368410003	BALAO EXTRATOR DE CALCULO MTW - COM INSERCAO PARAINJECAO DE CONTRASTE	Class II
BR	10368419001	BOCAL PARA ENDOSCOPIA	Class I
BR	10368410049	PINÇA CIRÚRGICA NÃO CORTANTE DESCARTÁVEL	Class II
CA	66548	CATHETER POUR INSEMINATION INTRO-UTERINE	Class II
CA	66549	EMBRYO TRANS SET	Class II
CA	66550	PRELEVINJEC	Class II

PRINCE MEDICAL SAS

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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