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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 3 of 3

Device	Model / Reference	Registries	Class	Status
AC Power Supply (Vivo 1-2-3)	006994	EUDAMED	Class I	Active
Apto® F01 Full Face Mask Medium	009973	EUDAMED	Class IIa	Active
Clearo Internal Battery	008283	EUDAMED	Class I	Active
Apto® N01 Nasal Mask Large	009989	EUDAMED	Class IIa	Active
MPV Kit (Circuit)	006236	EUDAMED	Class IIa	Active
Vivo 1	227000	EUDAMEDFDA UDI	Class IIb	Active
Breas Patient Circuit, Single Limb with Leakage Port, Disposable	005060	EUDAMED	Class IIa	Active
Single Limb Insert	005521	EUDAMEDFDA UDI	Class IIa	Active
Vivo 45/45LS/Nippy 4/4+ Click-in Battery	006265	EUDAMEDFDA UDI	Class I	Active
Lightweight Mobility Bag Vivo 1-2-3	007380	EUDAMEDFDA UDI	Class I	Active
Nurse call NC 10kOhm ODU cable	006362	EUDAMEDFDA UDI	Class I	Active
Z1 Battery Module	008769	EUDAMED	Class I	Active
Nurse call NO ODU cable	006365	EUDAMEDFDA UDI	Class I	Active
Effort Belt Communication Box	006182	EUDAMED	Class I	Active
MPV Arm	006095	EUDAMEDFDA UDI	Class I	Active
12 / 24 V Converter (Vivo 55/65)	004901	EUDAMEDFDA UDI	Class I	Active
Tube Adapter	005766	EUDAMED	Class IIa	Active
Vivo 45 LS	230000	EUDAMEDFDA UDI	Class IIb	Active
Z1 Battery Module	005769	EUDAMED	Class I	Active
Protective Cover Vivo 55/65	006344	EUDAMEDFDA UDI	Class I	Active
Vivo 3	229000	EUDAMEDFDA UDI	Class IIb	Active
Z1 QTube/Silencer	005997	EUDAMED	Class I	Active
Trolley Mounting Plate Vivo 1-2-3	006998	EUDAMED	Class I	Active
XPAC Single EU	007995	EUDAMED	Class I	Active
SpO2 Module	006369	EUDAMEDFDA UDI	Class I	Active
Breas Ventilator Trolley	007384	EUDAMEDFDA UDI	Class I	Active
Vivo 1/2/3 Humidifier	006977	EUDAMEDFDA UDI	Class IIa	Active
Nitelog	006003	EUDAMED	Class IIa	Active
SpO2 Adapter cable	007079	EUDAMEDFDA UDI	Class I	Active
Single Patient Breathing Hose	004465	EUDAMEDFDA UDI	Class IIa	Active
Z1 Power Shell	005767	EUDAMED	Class I	Active
Dual Limb Insert	005523	EUDAMEDFDA UDI	Class IIa	Active
Heated Patient Circuit Type 2	006990	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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