Tandem Health AB
Active in EUDAMEDSwedenfrom SRN EUDAMED SRN SE-MF-000049463
- Devices
- 5
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
Catalogue
- Regimes: CE MDR Registry: EUDAMED
Tandem AI Medical Guide Ref 3
Regimes: CE MDR Registry: EUDAMEDTandem AI Medical Scribe Ref 1
Regimes: CE MDR Registry: EUDAMEDTandem AI Medical Scribe Ref 1
Regimes: CE MDR Registry: EUDAMEDTandem AI Medical Coder Ref 2
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- SE-MF-000049463
- EU VAT number
- SE559444685701
- EUDAMED status
- Active
- EUDAMED registered name
- Tandem Health AB
- EUDAMED abbreviated name
- Tandem
- Registered address
- 12-14, Kungsgatan, 111 35, Stockholm, Sweden
- Website
- tandemhealth.ai
- [email protected]
- Phone
- +46 8 446 820 83
- PRRC contact
- Yan Peng Zhao
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 15 Feb 2031
Scarlet NB B.V. 3022 1 certificate
- SCAR-9.2.1.7 Active
Quality management system EU MDR
- Issued
- 16 Sep 2026
- Expires
- 15 Feb 2031
- Reason
- Other
From the company website
Tandem Health provides an AI medical assistant for healthcare professionals across general practice, mental health, nursing, social services, dentistry, veterinary care, physiotherapy, municipal healthcare services, and hospital settings. The platform combines AI-powered medical scribing, automated coding assistance, and AI clinical decision support - generating structured clinical documentation, setting diagnosis and procedure codes, and surfacing evidence-based guidance at the point of care. Tandem is available on a free plan and paid tiers, and is building toward a broader AI-native clinic operating system that supports clinicians across the full clinical workflow.
Frequently asked questions
How many devices does Tandem Health AB have in the registry?
The registry currently lists 5 devices for Tandem Health AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Tandem Health AB's devices?
Among its 5 most recently registered devices, Tandem Health AB has devices listed in EUDAMED (5 devices).
What risk classes do Tandem Health AB's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Tandem Health AB's devices are Class I and Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Tandem Health AB?
EUDAMED lists 1 certificate for Tandem Health AB (quality management system) under MDR. The most recent was issued on 16 Sep 2026.
What are the newest devices from Tandem Health AB in the registry?
The most recently registered devices listed for Tandem Health AB include Tandem AI Information Gatherer, Tandem AI Medical Guide, Tandem AI Medical Scribe and Tandem AI Medical Coder.