Brainlab SE
Active in EUDAMEDGermanyfrom SRN EUDAMED FDA SRN DE-MF-000006183 FEI 3002619595
Brainlab SE is a medical device manufacturer based in Germany, with 967 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II; EU Class I, IIb and IIa) as of 12 Nov 2026.
- Devices
- 967
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 927
- EUDAMED 441
- FDA 510(k) 2
- Device classes
- FDA Class II 507
- EU Class I 268
- EU Class IIb 111
- EU Class IIa 54
- FDA Class I 25
- EU Class III 2
- Top EMDN categories
- Identifiers
- EUDAMED SRN DE-MF-000006183
- FDA FEI 3002619595
- DUNS 314482980
At a glance
EU certificates
6 of 6 in force.
Market reach
- European Union
- EUDAMED actor, 6 certificates
- United States
- FDA FEI
What Brainlab SE makes
Brainlab SE manufactures neurological stereotactic surgery systems, including invasive head frames and robotic surgical navigation tools for precise cranial procedures. Their portfolio also includes multi-modality therapeutic radiation phantoms for testing, radiation therapy software, and medical image management systems. Electromagnetic and optical surgical navigation tracking systems, along with specialized suction cannulas, are designed for intraoperative guidance. Additional components like headpins, interface plates, and alignment reduction tubes support stereotactic radiosurgery and cranial fixation.
The company’s devices span regulatory classifications including Class I, Class II, Class IIa, Class IIb, and Class III under global standards. Products are listed in the EU’s eudamed registry and the U.S. FDA UDI database. The manufacturer is based in Germany.
Catalogue
Search and filter all 967 devicesShowing 1-50 of 967
Company details
- EUDAMED SRN
- DE-MF-000006183
- FDA FEI number
- 3002619595
- DUNS number
- 314482980
- EU VAT number
- DE 213 505 546
- EUDAMED status
- Active
- EUDAMED registered name
- Brainlab SE
- Registered address
- 9, Olof-Palme-Straße, 81829, Munich, Germany
- Phone
- +49899915680
- PRRC contact
- Antonia Wurmseher
EUDAMED certificates
6 certificates6 valid, 0 expiredMDR 6next expiry 13 Mar 2028
TÜV SÜD Product Service GmbH 0123 6 certificates
- G70 037489 0098 Active
Technical documentation EU MDR
- Issued
- 10 Feb 2026
- Expires
- 9 Feb 2031
- G10 037489 0059 Active
Quality management system EU MDR
- Issued
- 9 Sep 2025
- Expires
- 13 Sep 2030
- Valid from
- 14 Sep 2025
- G11 037489 0060 Active
Quality management system EU MDR
- Issued
- 9 Sep 2025
- Expires
- 26 Jun 2028
- Reason
- Mnf data change
- G12 037489 0070 Active
Quality management system EU MDR
- Issued
- 9 Sep 2025
- Expires
- 30 Mar 2028
- Reason
- Mnf data change
- G70 037489 0071 Active
Technical documentation EU MDR
- Issued
- 9 Sep 2025
- Expires
- 15 Mar 2028
- Reason
- Mnf data change
- G70 037489 0072 Active
Technical documentation EU MDR
- Issued
- 9 Sep 2025
- Expires
- 13 Mar 2028
- Reason
- Mnf data change
Frequently asked questions
How many devices does Brainlab SE have in the registry?
The registry currently lists 967 devices for Brainlab SE. Devices recorded under merged duplicate company entries are counted once.
Which registries list Brainlab SE's devices?
Among its 50 most recently registered devices, Brainlab SE has devices listed in EUDAMED (42 devices), FDA 510(k) (2 devices) and FDA GUDID (30 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Brainlab SE's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Brainlab SE's devices are Class I, Class IIa, Class IIb and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Brainlab SE?
EUDAMED lists 6 certificates for Brainlab SE (technical documentation; quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 10 Feb 2026.
What are the newest devices from Brainlab SE in the registry?
The most recently registered devices listed for Brainlab SE include Quip Link Instrument Tracking Array For 3 Marker Spheres ML, Quip Instrument Adapter Clamp For Cylindrical Instruments, Quip Link Instrument Tracking Array For 3 Marker Spheres L and Brainlab Elements, 7.1.