Baitella AG

Switzerland · Zürich · www.fisso.com

✓ Record-verifiedregistrations found in 4 marketsEU SRN CH-MF-000017307

This company has registrations in European Union, United States, United Kingdom, Australia — 4 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

72UDI-DI device records

Class I 72

USUnited StatesFDA openFDA

7listed device types

Class I 5Class II 2Class III 0

plus 7 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

9registered device records

Class I 9

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

8active ARTG entries

Class I 8

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 Union72 raw hits, 0 excluded, 72 confirmed

United States7 registration records, 1 510(k), 0 PMA

United Kingdom9 confirmed, 0 excluded

Manufacturer names merged into this page: BAITELLA AG

Regulatory identity

EU manufacturer SRN: CH-MF-000017307
EU authorised representative: Baitella GmbH
UK responsible person: confinis (UK) RP Ltd

FDA 510(k) clearances by year

12007 · K070509

FDA listed device types

Endoscope Holder 1Dermal Cooling Pack/Vacuum/Massager 1Circuit, Breathing (W Connector, Adaptor, Y Piece) 1Set, Tubing And Support, Ventilator (W Harness) 1Orthopedic Manual Surgical Instrument 1Operating Room Accessories Table Tray 1Support, Breathing Tube 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	07640152573149	FISSO Respiratory Circuit Holder	Class I
EU	07640152574276	FISSO Shoulder Pad	Class I
EU	07640152574269	FISSO Lateral Pad Circular	Class I
EU	07640152574252	FISSO Lateral Pad Wide	Class I
UK	37047	FISSO Arm Support Lateral	Class I
UK	37047	Fisso	Class I
UK	35504	FISSO Pressure Transducer Plate Holder	Class I
US	K070509	FISSO HOLDING SYSTEM	2007-03-22

Baitella AG

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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