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Paul Hartmann Corp.

Germany · Bruck Brandenburg

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Saudi Arabia — 3 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

pendingnot queried

USUnited StatesFDA openFDA

9listed device types

Class I 7Class II 1Class III 0unclassified 1

plus 19 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

18registered devices

Class I 13Class II 5

31 including historic records

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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.

United States19 registration records, 5 510(k), 0 PMA, 5 excluded

Brazil18 confirmed, 3 excluded

Saudi Arabia1 confirmed, 0 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: PAUL HARTMANN AG · PAUL HARTMANN Manufacturing Sp. z o.o. · PAUL HARTMANN SAS · PAUL HARTMANN S.A. · Paul Hartmann SA · PAUL HARTMANN AG - Plasto SAS

Same-named companies — This database also contains companies with near-identical names: PAUL HARTMANN Manufacturing Sp. z o.o., PAUL HARTMANN S.A.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

51984 · K843405

FDA listed device types

showing 8 of 9

Protector, Skin Pressure 1Garment, Protective, For Incontinence 1Reminder, Medication 1Dressing, Wound, Hydrophilic 1Tape And Bandage, Adhesive 1Bandage, Elastic 1Dressing, Wound, Occlusive 1Drape, Surgical, Exempt 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K843405	MOLICARE	1984-10-19
US	K843404	MOLINEA INCONTINENT PAD	1984-10-19
US	K843403	MOLINEA PANTY	1984-10-19
BR	80170319044	Vivanotec Pro	Class II
BR	80170310112	HydroTac® Transparent Face	Class I
BR	80170310102	Cosmopor I.V. Transparent	Class I
SA	ME0000001558SFDAA00490	DermaPlast® Universal	—

Paul Hartmann Corp.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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