Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

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: 04262458250949
Reference / catalog number: 360S-1-0

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Related devices

CellClip stainless steel426245825EC0ENOn the market CellClip stainless steel426245825EC0ENOn the market Celllspin III Basic R refrigerated, 220426245825CSP1AZOn the market Celllspin III Basic, 110V426245825CSP1AZOn the market Cellspin III Basic, 220V426245825CSP1AZOn the market

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: 04262458250949
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: 100
Additional product description: 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

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.