Regen Lab SA

Switzerland · Le Mont-Sur-Lausanne · www.regenlab.com

✓ Record-verifiedregistrations found in 11 marketsEU SRN CH-PR-000049402

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 11 overseas markets. EU UDI-DI records ≥55, 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

≥55UDI-DI device records

Class IIa 11Class IIb 33Class III 11

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 3Class II 3Class III 0

plus 9 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

8registered device records

Class IIa 2Class IIb 3Class III 3

BRBrazilANVISA

5registered devices

Class I 2Class II 3

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

1active device licences

Class II 1

7 including historic records

TWTaiwanTFDA

2valid device licences

Class II 1Class III 1

SGSingaporeHSA SMDR

6device registrations

CLASS B 4CLASS D 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class III 1IIb 1

HKHong KongMDACS

3valid listings

Class III 1Class IV 2

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

10active registrations

Class 2a 3Class 2b 1Class 3 6

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 Union312 raw hits, 245 excluded, 55 confirmed. Large result set — only the first 300 verified

United States9 registration records, 1 510(k), 0 PMA, 4 excluded

United Kingdom8 confirmed, 9 excluded

Brazil5 confirmed, 1 excluded

Canada1 confirmed, 1 excluded

Manufacturer names merged into this page: REGEN LAB Sa · REGEN LAB SA

Regulatory identity

EU manufacturer SRN: CH-PR-000049402
EU authorised representative: RegenLab France
UK responsible person: Vega Product Solutions Ltd

Business registration

LEI: 506700HK75Q84R5MXI38
Registration status: Inactive
Legal form: Società anonima (SA)
Incorporated: 2003-05-20
Registered address: Route de l'Ile-au-Bois 3, Monthey, 1870
Registration authority: UID-Register, no. CHE110064203
Registry record updated: 2026-08-27

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

12012 · K122122

FDA listed device types

Peripheral Blood Processing Device For Wound Management 1Platelet And Plasma Separator For Bone Graft Handling 1Syringe, Piston 1Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use 1Media And Components, Synthetic Cell And Tissue Culture 1Bottle, Roller, Tissue Culture 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	07640138982019	Accessory Set	Class IIa
EU	07640138982026	—	Class IIb
EU	07640138980114	Accessory Set	Class IIa
EU	07640138980343	Cellular Matrix A-CP-HA Kit	Class III
UK	47153	RegenKIT Extracell BMC	Class IIb
UK	46923	Regen Spray Applicator	Class IIa
UK	46923	A-CP-Kit-3	Class IIb
US	K122122	REGEN SPRAY APPLICATOR,	2012-11-09
BR	80686360117	Cellular Matrix BCT-HA	Class I
BR	80380260034	Centrífuga HORIZON 6FA	Class I
BR	80380269002	RegenCentri	Class II
CA	102142	REGENKIT EXTRACELL ADIPOCYTE	Class II