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RZ Medizintechnik GmbH

Germany · Tuttlingen · www.rz-medizintechnik.com

✓ Record-verifiedregistrations found in 12 marketsEU SRN DE-MF-000005616

This company has registrations in European Union, United States, United Kingdom, Brazil, Saudi Arabia, Canada, Taiwan, South Korea, Australia, Hong Kong, Israel, Russia — 12 overseas markets. EU UDI-DI records ≥10, 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

≥10UDI-DI device records

Class IIa 10

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

USUnited StatesFDA openFDA

191listed device types

Class I 171Class II 20Class III 0

plus 197 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

191registered device records

Class I 170Class IIa 12Class IIb 9

BRBrazilANVISA

68registered devices

Class I 36Class II 32

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

5registered imported devices

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

CACanadaMDALL

3active device licences

Class II 3

33 including historic records

TWTaiwanTFDA

15valid device licences

Class I 15

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

149active ARTG entries

Class I 136IIa 8IIb 5

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

3active registrations

Class 2a 3

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 Union9,564 raw hits, 90 excluded, 10 confirmed. Large result set — only the first 300 verified

United States197 registration records, 3 510(k), 0 PMA, 1 excluded

United Kingdom191 confirmed, 23 excluded

Brazil68 confirmed, 1 excluded

Saudi Arabia5 confirmed, 0 excluded

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: RZ MEDIZINTECHNIK GMBH · RZ Medizintechnik GmbH

Regulatory identity

EU manufacturer SRN: DE-MF-000005616
UK responsible person: MEDAGENT INTERNATIONAL UK LIMITED

Registration details (sample)

Market	Identifier	Name	Class / date
EU	04049197255523	—	Class IIa
EU	04049197255516	—	Class IIa
EU	04049197464970	—	Class IIa
EU	04049197464963	—	Class IIa
UK	36293	Haberer Bauchspatel 25/30 x 280 mm, biegsam	Class I
UK	10025	Laforce Adenotom gelocht 230mm, 12mm	Class I
UK	10089	Beacham Amniotom AL 260 mm	Class I
US	K243382	RZ Resectoscope System	2025-06-03
US	K130778	DISCOSCOPES, CERVICAL ENDOSCOPES	2014-04-14
US	K082902	RZ ENDOSCOPIC (MINIMALLY INVASIVE) INSTRUMENTS AND ACCESSORIES	2008-12-10
BR	81895419035	RZ Cistoscópio	Class II
BR	81895419037	RZ Endoscópio Espinhal	Class II
BR	81895419039	RZ Trocar não Destacável sem Válvula	Class II
SA	ME0000018066SFDAA00004	4K 3Chip Digital Camera System K4000	—
SA	ME0000018066SFDAA00007	HD-CAMERA F2 Pro	—
CA	31280	INSUFFLATION NEEDLE	Class II
CA	31285	FORCEPS AND SCISSORS	Class II
CA	63514	ENDOSCOPE WORKING ELEMENTS	Class II

RZ Medizintechnik 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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