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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

36216002 — IVDD — General IVDD by Gold Standard…

MD Atlas
Gold Standard Diagnostics Kassel GmbH

EUDAMED last updated this device on Aug 27, 2025

36216002

B-04260153751303

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: 04260153751303
Reference / catalog number: 36216002

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Manufacturer information

Organization name: Gold Standard Diagnostics Kassel GmbH
SRN: DE-MF-000021646
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.

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: 04260153751303
Basic UDI-DI: B-04260153751303
Reference / catalog number: 36216002
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: Positivkontrolle für Spez. IgE ELISA is a control serum suitable for checking the accuracy of the Gold Standard Diagnostics Kassel Specific IgE kits. It can only be used in combination with Gold Standard Diagnostics Kassel Specific IgE ELISA kits. The tests are designed for in vitro diagnostic use only. They are intended for manual performance by trained professional users.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01020202IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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