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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

AB0030 — IVDR Class A IVDR by APPOLON BIOTECK

MD Atlas
APPOLON BIOTECK

EUDAMED last updated this device on Apr 7, 2026

AB0030

376032282APAN2234K

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: APPOLON BIOTECK
UDI-DI code: 03760322820133
Reference / catalog number: AB0030

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Manufacturer information

Organization name: APPOLON BIOTECK
SRN: FR-MF-000022234
Manufacturer status: Active

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.
CW043
EUDAMED did not publish a description for this code.
CW041
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

Placed on the market in France; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 03760322820133
Basic UDI-DI: 376032282APAN2234K
Reference / catalog number: AB0030
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Magnetic bead-based nucleic acid extraction kit
Additional information URL: https://www.appolonbioteck.qarad.eifu.online/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105900101REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS

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

AB0038376032282APAN2234KOn the market AB0022376032282CGENHLAB27J6On the market MTL376032282APANMTLD8On the market AB0024376032282DINFSCFRRKOn the market KSC2-AB69B-KSC2-AB692FOn 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.