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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

SELco TSH rapid — IVDD — General IVDD by Medipan GmbH

MD Atlas
Medipan GmbH

EUDAMED last updated this device on Apr 9, 2025

SELco TSH rapid

B-04250278800086

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Medipan GmbH
UDI-DI code: 04250278800086
Reference / catalog number: 1450

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Manufacturer information

Organization name: Medipan GmbH
SRN: DE-MF-000032986
Manufacturer status: Active

Critical warnings

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

CW011
-
CW008
-
CW010
-
CW267
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CW266
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CW265
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CW263
-
CW009
-
CW028
Iodine-125 (< 0.98 MBq, t½ = 59 days; gamma radiation 35 keV, x radiation 27 keV, 31 keV)

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement	Jul 1, 2002	Still on market
Spain	Jun 20, 2006	Still on market

Device identification

Trade name: SELco TSH rapid
UDI-DI code: 04250278800086
Basic UDI-DI: B-04250278800086
Reference / catalog number: 1450
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: https://www.medipan.de/products/1450-selco-tsh-rapid/
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01020410THYROID STIMULATING HORMONE

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

This device is not currently linked to any other device.

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.