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Breas Medical AB

Sweden·SE-MF-000001061

Last updated September 17, 2026

What Breas Medical AB makes

Breas Medical AB manufactures reusable electrical connection cables for medical devices, portable electric ventilators (including the Vivo 65, Vivo 50, Vivo 45 LS, and Vivo 1/2 models), and reusable and single-use ventilator breathing circuits. The company also produces secondary batteries for ventilators, medical bags for device storage, ventilator converters, and nurse call system alarms.

The company’s products are regulated as Class I, Class II, Class IIa, and Class IIb devices, with listings in the EU’s EUDAMED registry, the FDA’s 510(k) clearance database, and the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in Sweden.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: Sweden
Address: 1, Företagsvägen, MÖLNLYCKE, Sweden
Website: www.breas.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +4631868800
PRRC Contact: Ivan Liljegren
EUDAMED SRN: SE-MF-000001061
FDA FEI Number: 3003244771
DUNS Number: 357007657

Catalogue (133)

Page 2 of 3

Device	Model / Reference	Registries	Class	Status
Z1 Slim-Style CPAP Tube	005797	EUDAMED	Class IIa	Active
Mounting bracket [for Vivo 45 and Nippy w. Trolley]	006761	EUDAMEDFDA UDI	Class I	Active
Apto® N01 Nasal Mask Small	009987	EUDAMED	Class IIa	Active
Nurse call NC ODU cable	006364	EUDAMEDFDA UDI	Class I	Active
XPAC Dual EU	007999	EUDAMED	Class I	Active
Vivo 2	228000	EUDAMEDFDA UDI	Class IIb	Active
Mounting plate, Vivo 50	007916	EUDAMEDFDA UDI	Class I	Active
Breas Vivo 40 System	K053607	FDA 510(k)	Class II	Active
Breas Isleep 20+	K061057	FDA 510(k)	Class II	Active
Breas Vivo 40 System	K090113	FDA 510(k)	Class II	Active
Breas Vivo Bilevel System, Model Vivo 40	K071702	FDA 510(k)	Class II	Active
Breas, Model Ha01	K060790	FDA 510(k)	Class II	Active
Breas Vivo Bilevel System, Model Vivo 30	K060546	FDA 510(k)	Class II	Active
Breas Isleep 20i	K063476	FDA 510(k)	Class II	Active
Isleep By Breas, Models Isleep 10, Isleep 20.	K060657	FDA 510(k)	Class II	Active
Click-In Humidifier	006490	EUDAMED	Class IIa	Active
Lightweight Bag (Vivo 45)	007555	EUDAMEDFDA UDI	Class I	Active
Apto® F01 Full Face Mask Large	009974	EUDAMED	Class IIa	Active
Z1 Auto	218000	EUDAMED	Class IIa	Active
Accessory Box Vivo 1-2-3	007000	EUDAMEDFDA UDI	Class I	Active
PtcCO2 cable Sentec	006179	EUDAMEDFDA UDI	Class I	Active
Nippy 4	226000	EUDAMED	Class IIb	Active
EveryWare by Breas (v1.x.x)	008393	EUDAMED	Class IIb	Active
EveryWare by Breas (v3.x.x)	190027	EUDAMED	Class IIb	Active
Remote Alarm w. ODU 10m cable	006348	EUDAMEDFDA UDI	Class I	Active
Remote Alarm w. ODU 25m cable	006349	EUDAMEDFDA UDI	Class I	Active
Vivo 50/55/60/65 PC Software USB	005100	EUDAMEDFDA UDI	Class IIb	Active
PowerShell	008768	EUDAMED	Class I	Active
VIvo 50/55/60/65 T-piece with plug	005120	EUDAMEDFDA UDI	Class IIa	Active
Dual Limb Insert	005525	EUDAMEDFDA UDI	Class IIa	Active
Vivo 55	221000	EUDAMED	Class IIb	Active
Remote Start/Stop Vivo 65	006342	EUDAMEDFDA UDI	Class I	Active
Nurse call NO 10kOhm ODU cable	006363	EUDAMEDFDA UDI	Class I	Active
Vivo 45 Protective cover	006067	EUDAMEDFDA UDI	Class I	Active
Patient circuit arm holder	007917	EUDAMEDFDA UDI	Class I	Active
PtcCO2 cable Radiometer	006180	EUDAMEDFDA UDI	Class I	Active
Vivo 65	225000	EUDAMED	Class IIb	Active
Remote Start/Stop (Vivo 45/Nippy 4)	006649	EUDAMEDFDA UDI	Class I	Active
Protective cover Vivo 1-2-3	007014	EUDAMEDFDA UDI	Class I	Active
Z1 Cpap	217000	EUDAMED	Class IIa	Active
Apto® F01 Full Face Mask Small	009972	EUDAMED	Class IIa	Active
PC Software Vivo 1/2/3/45/45LS/Nippy 4/4+	007067	EUDAMEDFDA UDI	Class IIb	Active
EveryWare by Breas (v2.x.x)	008512	EUDAMED	Class IIb	Active
Clearo	232000	EUDAMED	Class IIb	Active
Clearo Cough Circuit	008276	EUDAMED	Class IIa	Active
"Patient Circuit, Heated Wire with Cable Connector"	006193	EUDAMED	Class IIa	Active
Click-On Battery, Vivo 50/60 Series	004559	EUDAMEDFDA UDI	Class I	Active
Clearo IPPB Circuit	008277	EUDAMED	Class IIa	Active
Apto® N01 Nasal Mask Medium	009988	EUDAMED	Class IIa	Active
Patient Circuit, 15mm x 1.8m	006712	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

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Importers

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Notified Bodies

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Authorities

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FDA Recalls (5)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Breas Medical AB has five FDA recall records initiated between January 28, 2020, and July 25, 2024. The records include one classified, one open, and three terminated recalls. Reasons cited involve potential ventilator malfunctions, such as processor shutdowns without alarms, obstructed exhalation valves, detached mounting brackets, elevated formaldehyde emissions under specific conditions, and unintended slits in mouthpiece bodies affecting ventilation.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Jul 25, 2024	Z-2690-2024	—	open, classified	There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the device into the patient breathing airpath in specific conditions.
Oct 13, 2023	Z-0405-2024	—	open, classified	Produced with unintended open slits on the side of the mouthpiece body, may result in insufficient ventilation in spontaneous breathing patients using MPV-VCV and MPV-PCV modes of ventilation
Jun 2, 2022	Z-1382-2022	—	open, classified	A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into a failure AND the instructions to monitor a ventilator dependent patient are NOT followed, the health consequences could potentially be Permanent impairment or life threatening if medical intervention is not obtained
Mar 21, 2022	Z-0943-2022	—	terminated	Ventilator mounting brackets for the Vivo 50/60/65 and Vivo 45LS ventilator models can become detached from the Breas Ventilator Trolley, this may cause the ventilator to fall from the trolley and cause injury to a person who is in the immediate proximity
Jan 28, 2020	Z-1352-2020	—	terminated	The outlet hole of the exhalation valve control pressure tube on the ventilator may become obstructed by the protective cover.

FDA Establishments (2)

Establishments registered with the FDA under this company group, matched by name.

Breas Medical, Inc. US
Breas Medical Limited GB