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BioCer Entwicklungs-GmbH

✓ Record-verifiedregistrations found in 11 marketsEU SRN DE-MF-000007112

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 11 overseas markets. EU UDI-DI records ≥3, the first 300 verified individually. 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

≥3UDI-DI device records

Class I 1Class III 2

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

2listed device types

Class I 0Class II 2Class III 0

plus 1 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

4registered device records

Class I 1Class IIa 1Class IIb 1Class III 1

BRBrazilANVISA

2registered devices

Class II 2

3 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

2 including historic records

TWTaiwanTFDA

3valid device licences

Class II 2Class III 1

SGSingaporeHSA SMDR

2device registrations

CLASS C 1CLASS D 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

5active ARTG entries

Class III 3IIa 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

1active registrations

Class 3 1

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 Union409 raw hits, 297 excluded, 3 confirmed. Large result set — only the first 300 verified

United States1 registration records, 1 510(k), 0 PMA

United Kingdom4 confirmed, 1 excluded

Brazil2 confirmed, 0 excluded

Manufacturer names merged into this page: BIOCER ENTWICKLUNGS-GMBH · BIOCER ENTWICKLUNGS GMBH · BioCer Entwicklungs-GmbH

Regulatory identity

EU manufacturer SRN: DE-MF-000007112
UK responsible person: Qserve Group UK, Ltd.
Exhibition record: CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04260597440269	HaemoCer PLUS	Class III
EU	04260597440696	HaemoCer Endoscopic Applicator	Class I
EU	04260597441532	TiO2Mesh Anatomical 10 x 15 cm	Class III
UK	60300	TiO2Mesh Surgical Mesh Implant	Class IIb
UK	47186	HaemoCer Flex Applicator	Class IIa
UK	47186	HaemoCer Endoscopic Applicator	Class I
US	K113311	TIO2MESH TM	2012-07-17
BR	80003899016	Aplicador Haemocer Flex	Class II
BR	80003890108	Aplicador Universal HaemoCer	Class II

BioCer Entwicklungs-GmbH

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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