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

RM02 — Class IIa MDR by QuantièmePlus SA

MD Atlas
QuantièmePlus SA

EUDAMED last updated this device on Oct 2, 2025

RM02

764016863DARCDR

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: QuantièmePlus SA
UDI-DI code: 07640168630027
Reference / catalog number: RM02

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: QuantièmePlus SA
SRN: CH-MF-000011186
Manufacturer status: Active

Related devices

RM36764016863REUTJSOn the market RM32764016863REUTJSOn the market RM37764016863REUTJSOn the market RM34764016863REUTJSOn the market RM31764016863REUTJSOn 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

4 warnings recorded — scroll inside the panel to see all entries.

CW001
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Oct 7, 2022	Still on market

Device identification

Trade name: not provided
UDI-DI code: 07640168630027
Basic UDI-DI: 764016863DARCDR
Reference / catalog number: RM02
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: The Medical Device ReamerPlus consists in a range of sterile single use reamers, used for the establishment of a hip cup during a THA. RM02 = T42+T46+T48+T50+T52+T54 = Box STANDARD
Additional information URL: https://ifu.quantiemeplus.com/
Clinical sizes: RM02 = T42+T46+T48+T50+T52+T54 = Box STANDARD

EMDN nomenclature code(s)

P091301ORTHOPAEDIC IMPLANT REAMERS, SINGLE-USE

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