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Organization name
UDI-DI code
Reference / catalog number

AD001-04 — IVDR Class C IVDR by ADmit Therapeutics

MD Atlas
ADmit Therapeutics

EUDAMED last updated this device on Nov 27, 2025

AD001-04

8437026887AD001YH

On the marketIVDR Class C

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: ADmit Therapeutics
UDI-DI code: 08437026887049
Reference / catalog number: AD001-04

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Manufacturer information

Organization name: ADmit Therapeutics
SRN: ES-MF-000042518
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW999
See IFU

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Sep 15, 2025	Aug 25, 2030

Device identification

Trade name: not provided
UDI-DI code: 08437026887049
Basic UDI-DI: 8437026887AD001YH
Reference / catalog number: AD001-04
Issuing entity: GS1

Classification

Risk category: IVDR Class C
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: MAP-AD Test Oligos consists of a set of four specific oligonucleotides (Oligos): Oligo1-Fw, 08437026887018 Oligo1-Rev, 08437026887025 Oligo2-Fw, 08437026887032 Oligo2-Rev, 08437026887049
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0106010201ALZHEIMER'S DISEASE

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

AD001-018437026887AD001YHOn the market AD001-028437026887AD001YHOn the market AD001-038437026887AD001YHOn the market AD0028437026887AD002YKOn the market AD0028437026887AD002YKOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.