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Prim, S.A.

Spain · Mostoles (Madrid) · www.prim.es

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, United Kingdom, Brazil, Saudi Arabia, Taiwan, Israel — 6 overseas markets. 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

0UDI-DI device records

USUnited StatesFDA openFDA

14listed device types

Class I 14Class II 0Class III 0

plus 14 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

25registered device records

Class I 25

BRBrazilANVISA

1registered devices

Class I 1

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

SASaudi ArabiaSFDA

9registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

10registrations

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 Union5,951 raw hits, 100 excluded, 0 confirmed. Large result set — only the first 300 verified

United States14 registration records, 0 510(k), 0 PMA, 1 excluded

United Kingdom25 confirmed, 28 excluded

Brazil1 confirmed, 0 excluded

Saudi Arabia9 confirmed, 0 excluded

Manufacturer names merged into this page: PRIM, S.A. · PRIM,S.A. · PRIM S.A. · Prim S.A.

Regulatory identity

UK responsible person: Advena Ltd

Business registration

LEI: 959800M75M81U0Y2UX24
Registration status: Active
Legal form: Sociedad Anonima (S.A.)
Incorporated: 1966-07-21
Registration authority: Commercial Registry, no. 1000253229246
Registry record updated: 2026-08-18

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

FDA listed device types

showing 8 of 14

Orthosis, Corrective Shoe 1Sling, Arm, Overhead Supported 1Orthosis, Limb Brace 1Joint, Knee, External Brace 1Protector, Skin Pressure 1Orthosis, Lumbar 1Orthosis, Truncal/Orthosis, Limb 1Splint, Clavicle 1

Registration details (sample)

Market	Identifier	Name	Class / date
UK	36206	AIRTEX Ankle Stabilizing Figure 8 Bandage	Class I
UK	67635	Accessory: Immobilization Shourder strap	Class I
UK	13565	‘Aqua’ adhesive callus patches Ref. CC330	Class I
BR	80018110112	ORTESES BEBAX DE MEMBROS INFERIORES PRIM	Class I
SA	ME0000008600SFDAA00007	SWASH LP/LPII UPRIGHT SET	—
SA	ME0000008600SFDAA00005	SWASH LP/LPII THIGH CUFFS SET	—

Prim, S.A.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA listed device types

Registration details (sample)

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