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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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Organization name
UDI-DI code
Reference / catalog number

1 — Class IIa MDR by Tandem Health AB

MD Atlas
Tandem Health AB

EUDAMED last updated this device on May 21, 2026

1

735017982TANDEMSCRIBEAB

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Tandem Health AB
UDI-DI code: 07350179820033
Reference / catalog number: 1

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View device family (Basic UDI)

Manufacturer information

Organization name: Tandem Health AB
SRN: SE-MF-000049463
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Sweden; available across 1 country total.

Country	On market since	Until
SwedenPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 07350179820033
Basic UDI-DI: 735017982TANDEMSCRIBEAB
Reference / catalog number: 1
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://app.tandemhealth.ai/legal/instructions-for-use
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)07350179820033

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

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Related devices

2735017982TANDEMCODER53On the market

Certificates

Certificate health across this manufacturer's portfolio.

SCAR-9.2.1.3Amended
Quality management systemNotified body: 3022Expiry: Feb 15, 2031