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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

360S-1-0 — IVDR Class A IVDR by Tharmac GmbH

MD Atlas
Tharmac GmbH

EUDAMED last updated this device on Feb 4, 2026

360S-1-0

426245825GSSSE8

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Tharmac GmbH
UDI-DI code: 04262458250932
Reference / catalog number: 360S-1-0

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Manufacturer information

Organization name: Tharmac GmbH
SRN: DE-MF-000039165
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW057
EUDAMED did not publish a description for this code.
CW085
EUDAMED did not publish a description for this code.
CW100
EUDAMED did not publish a description for this code.
CW135
EUDAMED did not publish a description for this code.
CW139
EUDAMED did not publish a description for this code.
CW158
EUDAMED did not publish a description for this code.
CW167
EUDAMED did not publish a description for this code.
CW430
EUDAMED did not publish a description for this code.
CW444
EUDAMED did not publish a description for this code.
CW291
EUDAMED did not publish a description for this code.
CW304
EUDAMED did not publish a description for this code.
CW038
EUDAMED did not publish a description for this code.
CW043
EUDAMED did not publish a description for this code.
CW044
EUDAMED did not publish a description for this code.

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: 04262458250932
Basic UDI-DI: 426245825GSSSE8
Reference / catalog number: 360S-1-0
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: Intended Use: Intended Use For independent collection of vaginal smears. Appropriate for laboratory-based testing for HPV pathogens.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0599IVD GENERAL USE CONSUMABLE DEVICES - 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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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.