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

Roeko Stopper — Class I MDR by Polydentia SA

MD Atlas
Polydentia SA

EUDAMED last updated this device on Nov 15, 2021

Roeko Stopper

++E299ROEKOSTOPPERBQ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Polydentia SA
UDI-DI code: +E2993310000
Reference / catalog number: 331000

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: Polydentia SA
SRN: CH-MF-000008779
Manufacturer status: Active

Related devices

pinky wood wedges++E299WOODWEDGESLEOn the market Precimatrix sectional matrices++E299DENTALICAMATRICES7BOn the market Precimatrix sectional matrices++E299DENTALICAMATRICES7BOn the market Quickmat All-round circumferential posterior matrices++E299RETAINERANDSPOOLSBQOn the market QuickmatFLEX sectional matrices++E299METALMATRICESM6On 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.

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW009
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: Roeko Stopper
UDI-DI code: +E2993310000
Basic UDI-DI: ++E299ROEKOSTOPPERBQ
Reference / catalog number: 331000
Issuing entity: HIBCC

Classification

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

Device details

Quantity: 50
Additional product description: Aid for setting the lenght of root canal instruments.
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