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

Actodent Spray — Class I MDR by ACTO GmbH

MD Atlas
ACTO GmbH

EUDAMED last updated this device on Mar 12, 2026

Actodent Spray

4250108324.IMLS.01TH

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ACTO GmbH
UDI-DI code: 04250108374046
Reference / catalog number: 03.7403.500

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: ACTO GmbH
SRN: DE-MF-000019128
Manufacturer status: Active

Market distribution

Primary placement in Türkiye; available across 1 country total.

Placed on the market in Türkiye; per-country availability dates not published.

Device identification

Trade name: Actodent Spray
UDI-DI code: 04250108374046
Basic UDI-DI: 4250108324.IMLS.01TH
Reference / catalog number: 03.7403.500
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M9002PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)

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

Related devices

06.3798.10M5B-05906190437143On the market 06.3818.10B-04250108338154On the market 06.3818.100B-04250108338130On the market 06.3818.05MB-04250108338178On the market 06.3818.30B-04250108338185On the market

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.