HomeGermanyMedSkin Solutions Dr. Suwelack AG

MedSkin Solutions Dr. Suwelack AG

Germany · Billerbeck · www.medskin-suwelack.com
✓ Record-verifiedregistrations found in 11 marketsEU SRN DE-MF-000007747

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 11 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
71UDI-DI device records
Class III 71
USUnited StatesFDA openFDA
3listed device types
Class I 0Class II 1Class III 0unclassified 2
plus 6 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
2registered device records
Class III 2
BRBrazilANVISA
0registered devices
1 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
1 including historic records
TWTaiwanTFDA
1valid device licences
Class III 1
SGSingaporeHSA SMDR
1device registrations
CLASS D 1
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
3active ARTG entries
Class III 3
HKHong KongMDACS
1valid listings
Class IV 1
ILIsraelAMAR
1registrations
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.

European Union71 raw hits, 0 excluded, 71 confirmed
United States6 registration records, 3 510(k), 0 PMA
United Kingdom2 confirmed, 0 excluded
Manufacturer names merged into this page: MedSkin Solutions Dr. Suwelack AG · MEDSKIN SOLUTIONS DR. SUWELACK AG

Regulatory identity

EU manufacturer SRN
DE-MF-000007747
UK responsible person
Emergo Consulting (UK) Limited

Company information

Country
Germany
City
Billerbeck
Website
www.medskin-suwelack.com
Product categories
Manufacturing, Lifecycle & Obsolescence ManagementCDMO (Contract Development and Manufacturing Organization)General Product Development, Development & Design Transfer

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
391200O2DF3QO0YUPN51
Registration status
Active
Legal form
Aktiengesellschaft (AG)
Incorporated
1997-10-15
Registration authority
Commercial Register, no. HRB 2366
Registry record updated
2026-05-29

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

12021 · K201577
12025 · K250864
12026 · K261224

FDA listed device types

Dressing, Wound, Drug 1Wound Dressing With Animal-Derived Material(S) 1Filler, Bone Void, Calcium Compound 1

Registration details (sample)

MarketIdentifierNameClass / date
EU04250569301513MatriDerm Flex Dermal MatrixClass III
EU04250569301506MatriDerm Flex Dermal MatrixClass III
EU04250569301490MatriDerm Flex Dermal MatrixClass III
EU04250569301483MatriDerm Flex Dermal MatrixClass III
UK45023Cutimed EpionaClass III
UK45023MatriDerm Dermal MatrixClass III
USK261224MatriDerm2026-05-14
USK250864MatriDerm pluS+ Bi-Layer2025-12-19
USK201577MatriDerm2021-01-07

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