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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

Imegen-Quimera Q116-42I dPCR Dry — IVDD — General IVDD

MD Atlas
Health in Code, S.L.

EUDAMED last updated this device on May 25, 2026

Imegen-Quimera Q116-42I dPCR Dry

B-08436589880559

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Health in Code, S.L.
UDI-DI code: 08436589880559
Reference / catalog number: IMG-116-53 Dry

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View device family (Basic UDI)

Manufacturer information

Organization name: Health in Code, S.L.
SRN: ES-MF-000054848
Manufacturer status: Active

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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.

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Aug 9, 2017	Still on market

Device identification

Trade name: Imegen-Quimera Q116-42I dPCR Dry
UDI-DI code: 08436589880559
Basic UDI-DI: B-08436589880559
Reference / catalog number: IMG-116-53 Dry
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://healthincode.com/
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)08436589880559

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EMDN nomenclature code(s)

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

W0106010499POLYMORPHISM TESTS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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