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Brainlab Ltd

Active in EUDAMED

Israelfrom SRN EUDAMED FDA SRN IL-MF-000008781 FEI 3005225421

Part of Brainlab AG

Brainlab Ltd is a medical device manufacturer based in Israel, with 5 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II; EU Class IIa) as of 13 Nov 2026.

Devices
5
Registrations
EUDAMEDFDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA GUDID 4
  • EUDAMED 3
  • FDA 510(k) 2

A device listed in two registries counts in both.

Device classes
  • FDA Class II 4
  • EU Class IIa 1
Top EMDN categories
Sites and related companies
Identifiers
  • EUDAMED SRN IL-MF-000008781
  • FDA FEI 3005225421
  • DUNS 533769907

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate
United States
FDA FEI
Authorised rep.
AR Experts B.V.NL

Catalogue5

Newest first, rows 1-5 of 5

  • TraumaCad 2.5

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • TraumaCad Neo 1.1

    Active Regimes: 510(k) Registry: GUDID Class:II

  • TraumaCad Neo Ref K231498

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • TraumaCad Neo (1.1) Ref K243810

    Active Regimes: CE MDR 510(k) Registry: EUDAMED510(k)GUDID Class:II

  • TraumaCad Mobile Ref 07290109942001

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
IL-MF-000008781
FDA FEI number
3005225421
DUNS number
533769907
EU VAT number
513417121
EUDAMED status
Active
EUDAMED registered name
Brainlab Ltd.
Registered address
35, Efal, 4951132, Petach-Tikva, Israel
Phone
+972 3 929 09 29
PRRC contact
Yael Guttentag(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 1 Sep 2028

EUDAMED certificates (1)

DEKRA Certification B.V. 0344 1 certificate

  • 3902756CE01 Active Amended

    Quality management system EU MDR

    Issued
    24 Oct 2025
    Expires
    1 Sep 2028
    Reason
    Mnf ar change

Frequently asked questions

How many devices does BRAINLAB LTD have in the registry?

The registry currently lists 5 devices for BRAINLAB LTD. Devices recorded under merged duplicate company entries are counted once.

Which registries list BRAINLAB LTD's devices?

Among its 5 most recently registered devices, BRAINLAB LTD has devices listed in EUDAMED (3 devices), FDA 510(k) (2 devices) and FDA GUDID (4 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do BRAINLAB LTD's devices fall under?

Among its 5 most recently registered devices, the classes recorded for BRAINLAB LTD's devices are Class IIa and Class II. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for BRAINLAB LTD?

EUDAMED lists 1 certificate for BRAINLAB LTD (quality management system) under MDR. The most recent was issued on 24 Oct 2025.

What are the newest devices from BRAINLAB LTD in the registry?

The most recently registered devices listed for BRAINLAB LTD include TraumaCad 2.5, TraumaCad Neo 1.1, TraumaCad Neo and TraumaCad Neo (1.1).

Generated automatically from registry data and not verified by a human reviewer.