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RESORBA Medical GmbH

Germany · Nurnberg

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, 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

pendingnot queried

USUnited StatesFDA openFDA

8listed device types

Class I 1Class II 7Class III 0

plus 5 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

4 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

4 including historic records

TWTaiwanTFDA

2valid device licences

Class II 1Class III 1

SGSingaporeHSA SMDR

2device registrations

CLASS D 1D WITH MEDICINAL PRODUCT 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

13active ARTG entries

Class III 11IIb 2

HKHong KongMDACS

2valid listings

Class IV 2

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

10active registrations

Class 2a 1Class 3 9

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 States5 registration records, 4 510(k), 0 PMA, 1 excluded

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: RESORBA Medical GmbH · RESORBA MEDICAL GMBH · Resorba Medical GmdH

FDA 510(k) clearances by year

12014 · K141072

22015 · K143584

12018 · K181320

FDA listed device types

Suture, Nonabsorbable, Silk 1Suture, Nonabsorbable, Synthetic, Polypropylene 1Suture, Nonabsorbable, Synthetic, Polyethylene 1Suture, Nonabsorbable, Synthetic, Polyamide 1Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile 1Suture, Absorbable, Synthetic, Polyglycolic Acid 1Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride) 1Gauze / Sponge,Nonresorbable For External Use 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K181320	Caprolon	2018-09-18
US	K143584	PGA RESORBA, PGA RESOQUICK, GLYCOLON	2015-11-02
US	K143582	MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL	2015-10-29
BR	10356500068	FIO DE SUTURA DE POLIAMIDA RESORBA	Class II