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Telea Electronic Engineering s.r.l.

Italy · Sandrigo (VI) · www.teleamedical.com

✓ Record-verifiedregistrations found in 10 marketsEU SRN IT-MF-000009973

This company has registrations in European Union, United States, United Kingdom, Brazil, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

13UDI-DI device records

Class IIb 13

USUnited StatesFDA openFDA

2listed device types

Class I 0Class II 2Class III 0

plus 1 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

7registered device records

Class I 2Class IIa 2Class IIb 3

BRBrazilANVISA

2registered devices

Class 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

0valid device licences

SGSingaporeHSA SMDR

2device registrations

CLASS B 1CLASS C 1

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

3active ARTG entries

Class I 2IIa 1

HKHong KongMDACS

4valid listings

Class III 4

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

1active registrations

Class 2b 1

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 Union14 raw hits, 1 excluded, 13 confirmed

United States1 registration records, 2 510(k), 0 PMA

United Kingdom7 confirmed, 0 excluded

Brazil2 confirmed, 0 excluded

Manufacturer names merged into this page: TELEA ELECTRONIC ENGINEERING S.R.L. · Telea Electronic Engineering S. r. l.

Regulatory identity

EU manufacturer SRN: IT-MF-000009973
UK responsible person: ALTRION GROUP UK Ltd

Business registration

LEI: 815600541A87AA13AC37
Registration status: Active
Legal form: Società A Responsabilità Limitata (SRL)
Incorporated: 1988-01-12
Registered address: VIA LEONARDO DA VINCI, 13, SANDRIGO, 36066
Registration authority: Business Register, no. 01969870243
Registry record updated: 2025-09-11

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

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08034055291658	turb bi-probe SMART monouso STERILE	Class IIb
EU	08034055294055	turb bi-probe monouso STERILE	Class IIb
EU	08034055290224	Manipolo a pedale pluriuso 3m	Class IIb
EU	08034055290231	Manipolo a dito pluriuso 3m	Class IIb
UK	35041	adapter for single-use plates with elastic band	Class I
UK	44776	STERILE single use NON-STICK bipolar bayonet forceps L=165mm T=0,50mm with SMART cable	Class IIb
UK	11490	Neutral insulated plate for adults	Class IIb
US	K152933	Vesalius	2016-03-23
US	K131696	VESALIUS	2014-01-31
BR	10355870177	ELETRODO MONOPOLAR DESCARTÁVEL DE TUNGSTÊNIO	Class II
BR	10355870178	ELETRODO BIPOLAR DESCARTÁVEL	Class II

Telea Electronic Engineering s.r.l.

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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