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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

RM16 — Class IIa MDR by QuantièmePlus SA

MD Atlas
QuantièmePlus SA

EUDAMED last updated this device on Oct 2, 2025

RM16

764016863REUTJS

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: QuantièmePlus SA
UDI-DI code: 07640168630164
Reference / catalog number: RM16

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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

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

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: 07640168630164
Basic UDI-DI: 764016863REUTJS
Reference / catalog number: RM16
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 D-Reamer consists in a range of non-sterile reusable reamers, used for the establishment of a hip cup during a THA. RM16 = T60
Additional information URL: https://ifu.quantiemeplus.com/
Clinical sizes: 60 MU50

EMDN nomenclature code(s)

L091102ORTHOPAEDIC PROSTHESES REAMERS AND 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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification