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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

36120000 — IVDD — General IVDD by Gold Standard…

MD Atlas
Gold Standard Diagnostics Kassel GmbH

EUDAMED last updated this device on Jun 11, 2025

36120000

B-361200007G

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Gold Standard Diagnostics Kassel GmbH
UDI-DI code: 361200007G
Reference / catalog number: 36120000

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Manufacturer information

Organization name: Gold Standard Diagnostics Kassel GmbH
SRN: DE-MF-000021646
Manufacturer status: Active

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.

Market distribution

Primary placement in Germany; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 361200007G
Basic UDI-DI: B-361200007G
Reference / catalog number: 36120000
Issuing entity: HIBCC

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: The "Referenzreihe Spez. IgE" is used to extend / supplement the "Specific IgE ELISA Kit (S or XL)" in order to be able to generate more reference series when samples are processed in different runs
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0102152299STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER

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

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