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Home›Spain›PAUL HARTMANN S.A.

PAUL HARTMANN S.A.

Spain · Mataro Barcelona
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 9 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
12valid device licences
Class I 10Class II 2
SGSingaporeHSA SMDR
19device registrations
CLASS B 13CLASS C 6
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
22active ARTG entries
Class I 10Class III 1IIa 3IIb 6Class Is (sterile) 2
HKHong KongMDACS
10valid listings
Class II 2Class III 8
ILIsraelAMAR
18registrations
RURussiaRoszdravnadzor
60active registrations
Class 1 37Class 2a 14Class 2b 7Class 3 2
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 Corp., PAUL HARTMANN Manufacturing Sp. z o.o.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Spain
City
Mataro Barcelona

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.

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)

MarketIdentifierNameClass / date
USK843405MOLICARE1984-10-19
USK843404MOLINEA INCONTINENT PAD1984-10-19
USK843403MOLINEA PANTY1984-10-19
BR80170319044Vivanotec ProClass II
BR80170310112HydroTac® Transparent FaceClass I
BR80170310102Cosmopor I.V. TransparentClass I
SAME0000001558SFDAA00490DermaPlast® Universal—

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