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

194.12XL modeling instr. n1 — Class I MDR by Prodont-Holliger

MD Atlas
Prodont-Holliger

EUDAMED last updated this device on Jan 20, 2026

194.12XL modeling instr. n1

3665224AMALGAMINSTR3J

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Prodont-Holliger
UDI-DI code: 03665224025528
Reference / catalog number: 194.12XL

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: Prodont-Holliger
SRN: FR-MF-000000956
Manufacturer status: Active

Related devices

105.00 crown remover3665224DAVIERSUPOn the market 106.28D spatula double for cement3665224BURNISHERPTOn the market 106.28XL burnisher design3665224BURNISHERPTOn the market 106.29D burnisher sple n° 28 xl3665224BURNISHERPTOn the market 106.29XL BURNISHER Design3665224BURNISHERPTOn 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.

Market distribution

Primary placement in France; available across 1 country total.

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

Device identification

Trade name: 194.12XL modeling instr. n1
UDI-DI code: 03665224025528
Basic UDI-DI: 3665224AMALGAMINSTR3J
Reference / catalog number: 194.12XL
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)

Q010199CONSERVATIVE DENTISTRY AND ENDODONTICS 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