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

HammTek-Business — Class IIa MDR by Hammtek oy

MD Atlas
Hammtek oy

EUDAMED last updated this device on Feb 24, 2025

HammTek-Business

642981149900175

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Hammtek oy
UDI-DI code: 64298114990012
Reference / catalog number: HammTek-Business

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: Hammtek oy
SRN: FI-MF-000033354
Manufacturer status: Active

Market distribution

Primary placement in Finland; available across 1 country total.

Country	On market since	Until
FinlandPrimary placement	Mar 1, 2025	Dec 31, 2025

Device identification

Trade name: not provided
UDI-DI code: 64298114990012
Basic UDI-DI: 642981149900175
Reference / catalog number: HammTek-Business
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: HammTek is an AI-powered device designed for quick, simple, and cost-effective oral health monitoring. It captures high-resolution videos of the teeth and gums, enabling early detection of dental abnormalities. To ensure hygienic use after each session, the device is used in combination with a CE-marked UV sterilization box. HammTek is intended for healthcare providers, nursing homes, and wellbeing areas.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 200 MU24
21 MU10
5 MU10

EMDN nomenclature code(s)

Q0199ODONTOLOGY DEVICES - OTHER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

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.

Related devices

This device is not currently linked to any other device.