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Delta Med S.p.A.

Italy · Viadana (MN) · numantec.eu

✓ Record-verifiedregistrations found in 10 marketsEU SRN IT-PR-000056955

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Singapore, Australia, Hong Kong, Israel, Russia — 10 overseas markets. EU UDI-DI records ≥28, 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

≥28UDI-DI device records

Class I 16Class IIa 12

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

USUnited StatesFDA openFDA

7listed device types

Class I 1Class II 6Class III 0

plus 11 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

13registered device records

Class I 4Class IIa 8Class IIb 1

BRBrazilANVISA

5registered devices

Class I 1Class II 4

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

6 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIb 1

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 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 Union3,660 raw hits, 272 excluded, 28 confirmed. Large result set — only the first 300 verified

United States11 registration records, 4 510(k), 0 PMA, 20 excluded

United Kingdom13 confirmed, 4 excluded

Brazil5 confirmed, 2 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: DELTA MED SPA · Delta Med SpA · DELTA MED S.P.A.

Regulatory identity

EU manufacturer SRN: IT-PR-000056955
UK responsible person: Donawa Lifescience Ltd

Business registration

LEI: 8156007862622C690C27
Registration status: Active
Legal form: Società Per Azioni (SPA)
Incorporated: 1993-09-22
Registered address: VIA GUIDO ROSSA, 20, VIADANA, 46019
Registration authority: Business Register, no. 01693020206
Registry record updated: 2026-07-24

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 · K121007

12014 · K140175

12017 · K171530

12020 · K200373

FDA listed device types

Device, Cystometric, Hydraulic 1Syringe, Piston 1Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days 1Set, Administration, Intravascular 1General Surgery Tray 1Cystometer, Electrical Recording 1Catheter, Infusion 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08032248041004	Assembled System for implantation procedures PICC PW ING	Class I
EU	08032248041011	Cesarean section assembled system	Class I
EU	08032248041028	Implantable Port Assembly System	Class I
EU	08032248041035	Implantable Port Assembly System	Class I
UK	31667	Ott.due vie DM 14G 45mm/s	Class IIa
UK	31667	Obturator Terumo dual entry	Class IIa
UK	64998	Delta transfer set	Class I
US	K200373	Deltaven Fast Flash Closed I.V. Catheter Systems	2020-08-26
US	K171530	Deltaven XiV Max, Deltaven XiV Max FF	2017-12-21
US	K140175	INTRAVASCULAR ADMINISTRATION SET	2014-08-05
BR	10178019048	Cateter Long Cânula Delta	Class II
BR	10178019044	CATETER MIDLINE POW DELTA	Class II
BR	10178019045	CATETER CANULA LONGA DELTA	Class II
CA	92023	NEO DELTA VEN XIV INTRAVENOUS CATHETERS	Class II