HomeGermanyAsclepion Laser Technologies GmbH

Asclepion Laser Technologies GmbH

Germany · Jena
✓ 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
2listed device types
Class I 0Class II 2Class III 0
plus 14 registration records and 29 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
6 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
15active device licences
Class II 8Class III 7
29 including historic records
TWTaiwanTFDA
16valid device licences
Class I 2Class II 14
SGSingaporeHSA SMDR
5device registrations
CLASS C 5
KRSouth KoreaMFDS GMP
3GMP quality-system certificates
Business type not stated 1Import 2
AUAustraliaTGA ARTG
18active ARTG entries
IIa 10IIb 8
HKHong KongMDACS
5valid listings
Class III 5
ILIsraelAMAR
11registrations
RURussiaRoszdravnadzor
13active registrations
Class 2a 2Class 2b 11
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 States14 registration records, 29 510(k), 0 PMA, 1 excluded
Brazil1 confirmed, 0 excluded
Canada15 confirmed, 0 excluded
Manufacturer names merged into this page: Asclepion Laser Technologies GmbH · ASCLEPION LASER TECHNOLOGIES GMBH

Company information

Country
Germany
City
Jena

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

12004
12005
42006
12007
12009
12011
22012
32014
42015
12017
12020
22022
12023
42024
12025
12026

FDA listed device types

Powered Laser Surgical Instrument 1Laparoscope, General & Plastic Surgery 1

Registration details (sample)

MarketIdentifierNameClass / date
USK261094YellowStar2026-04-29
USK253100MultiPulse TFL2025-10-23
USK240831MultiCut Solo2024-11-06
BR80047309178MULTICUT SOLOClass II
CA76351MEDIOSTAR HANDPIECE TIPSClass II
CA77667MCL 30 DERMABLATE LASERSClass III
CA78998APL HANDPIECEClass II

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