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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Tandem AI Medical Scribe — 1 UDI-DI variant, MDR (Tandem Health AB)

MD Atlas
Tandem Health AB

Data from EUDAMED, last updated May 31, 2026

Tandem AI Medical Scribe

735017982TANDEMSCRIBEAB

1 UDI-DI variant

MDR [Regulation (EU) 2017/745 on medical devices]Class IIa

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Manufacturer: Tandem Health AB

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Device characteristics

Active device

Legacy certificates

Certificate number: SCAR-9.2.1.3
Type: refdata.certificate-mdr-type.quality-management-system
Notified body: Scarlet NB B.V. (3022)
Validity: May 26, 2026 → Feb 15, 2031

Identity & classification

Basic UDI-DI: 735017982TANDEMSCRIBEAB
Device name: Tandem AI Medical Scribe
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Special device type: refdata.special-mdr-device-type.software
Version date: May 21, 2026

Manufacturer & authorised representative

Manufacturer

Name: Tandem Health AB
SRN: SE-MF-000049463
Country: Sweden
Email: support@tandemhealth.ai
Phone: +46 8 446 820 83

Variants by status

UDI-DI variants

1 UDI-DI variant

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basicUdiUlid01KS587PV9ZEAM6XDHF2JK59AK

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

107350179820033