Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners 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

RM639.035HP-12 — Class IIa MDR by Edenta Etablissement

MD Atlas
Edenta Etablissement

EUDAMED last updated this device on Nov 13, 2023

RM639.035HP-12

++E31217761EX

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Edenta Etablissement
UDI-DI code: E312RM639035HP121
Reference / catalog number: RM639.035HP-12

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?

View device family (Basic UDI)

Manufacturer information

Organization name: Edenta Etablissement
SRN: LI-MF-000011937
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

EasyUDICompliance engine

Sponsored

Your devices, UDI-compliant — without drowning in regulation

EUDAMED-ready· UDI-enriched

Basic UDIUDI-DIUDI-PIAttributeDocument

Print-ready label

From your product file — no manual entry

Exclusive to MD Atlas usersClaim my −20% discount

by Made In Tracker

Market distribution

Primary placement in Liechtenstein; available across 1 country total.

Country	On market since	Until
LiechtensteinPrimary placement	Dec 1, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: E312RM639035HP121
Basic UDI-DI: ++E31217761EX
Reference / catalog number: RM639.035HP-12
Issuing entity: HIBCC

Classification

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

Device details

Quantity: 12
Additional product description: —
Additional information URL: https://www.edenta.com/
Clinical sizes: 3.5 MU50

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

E312RM639035HP121

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

L159007ODONTOSTOMATOLOGY BURS, REUSABLE

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

Become a partner of MD Atlas

Related devices

0055FG-12++E31216412DUOn the market 0053FG-12++E31216412DUOn the market 0055FG-100++E31216412DUOn the market 0053FG-100++E31216412DUOn the market 0153FG-12++E31216412DUOn the market

Certificates

Certificate health across this manufacturer's portfolio.

1000183128Issued
Quality management systemNotified body: 0297Expiry: Mar 26, 2030