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Click-On Battery, Vivo 50/60 Series

EUDAMEDFDA UDIFDA 510(k)

Class I (EU MDR)

Ref 004559Model Class I Ventilator Accessories

by Breas Medical AB

Identity

Trade Name
Click-On Battery, Vivo 50/60 Series EUDAMED
Vivo 50, VIvo 65 FDA UDI
Generic Name
Secondary battery FDA UDI
Device Name
Click-On Battery FDA UDI
Model / Reference
Class I Ventilator Accessories EUDAMED
004559 EUDAMEDFDA UDI
Description
Click-On Battery FDA UDI

Identifiers

Catalog Number
004559 FDA UDI
Primary DI / UDI-DI
07321820045594 EUDAMEDFDA UDI
Basic UDI-DI
7321820139999H EUDAMED
FDA Product Code
CBK FDA UDI
NOU FDA UDI
EMDN Code
Z1203019080 VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - HARDWARE ACCESSORIES EUDAMED
GMDN Term
Secondary battery FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
868.5895 FDA UDI
Market of Registration
Sweden EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Click-On Battery, Vivo 50/60 Series by Breas Medical AB — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Breas Medical AB
EUDAMED SRN
SE-MF-000001061

Sources (3)

  • EUDAMED 2f047845-b194-4a58-92f7-08cbaba94c32 61 fields · synced Jun 18, 2026
  • FDA UDI 4de81629-4223-43f6-8f19-910786747eaa 35 fields · synced May 30, 2026
  • FDA 510(k) K160481 1 fields · synced May 18, 2026