HomeGermanyPrimed Halberstadt Medizintechnik GmbH

Primed Halberstadt Medizintechnik GmbH

Germany · Halberstadt · www.primed-halberstadt.de
✓ Record-verifiedregistrations found in 8 marketsEU SRN DE-MF-000004967

This company has registrations in European Union, United States, United Kingdom, Brazil, Singapore, Australia, Israel, Russia — 8 overseas markets. EU UDI-DI records ≥300, 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
≥300UDI-DI device records
Class I 2Class IIa 3Class IIb 295
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
1510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
33registered device records
Class I 13Class IIa 11Class IIb 7System or Procedure Pack 2
BRBrazilANVISA
41registered devices
Class II 41
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
4device registrations
CLASS B 1CLASS C 3
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
4active ARTG entries
IIa 1IIb 2Class Is (sterile) 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
3registrations
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 Union1,944 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified
United States0 registration records, 1 510(k), 0 PMA
United Kingdom33 confirmed, 0 excluded
Brazil41 confirmed, 0 excluded
Manufacturer names merged into this page: PRIMED HALBERSTADT MEDIZINTECHNIK GMBH

Regulatory identity

EU manufacturer SRN
DE-MF-000004967
UK responsible person
Advena Ltd
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai)

Company information

Country
Germany
City
Halberstadt
Employees
100–500
Company type
Manufacturer
Website
www.primed-halberstadt.de
Product categories
Integrated Care, Rehabilitation & HomecareConsumables, disposables & infection control

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

LEI
529900VETBO6VANQ3833
Registration status
Active
Legal form
Gesellschaft mit beschränkter Haftung (GmbH)
Incorporated
1990-09-05
Registration authority
Commercial Register, no. HRB 100724
Registry record updated
2025-10-15

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 · K120079

Registration details (sample)

MarketIdentifierNameClass / date
EU04250203249843Gold Marker 0,4 x 5 mm (Au 999), set of 1 pieceClass IIb
EU04250203249829Gold Marker knurled 1,2 x 3 mm (Au 999), set of 4 piecesClass IIb
EU04250203249805Gold Marker knurled 1,2 x 3 mm (Au 999), set of 3 piecesClass IIb
EU04250203249782Gold Marker knurled 1,2 x 3 mm (Au 999), set of 1 pieceClass IIb
UK11305Capillary drain AD= 8 mm, L= 500 mmClass IIa
UK35824Active -Passive Drainage System with universal connector, Inclusive: Drain Tube and Trocar Ch. 14, L=800 I 150 mm, sterileClass IIa
UK35824Active -Passive Drainage System with universal connector, Inclusive: Drain Tube and Trocar Ch. 14, L=800 I 150 mm, sterileClass IIa
USK120079PRIMED TRACHEOSTOMY TUBES (MULTIPLE)2012-05-24
BR81573249054ProLine Suction Voice e ProLine XT Suction VoiceClass II
BR81573249055PRIMED PEDIÁTRICA CUFFClass II
BR81573249056PRIFLEX CUFF FENESTRADAClass II

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