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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

H146 — Class I MDR by Implants Diffusion…

MD Atlas
Implants Diffusion International

EUDAMED last updated this device on Apr 12, 2022

H146

03662174REUINSTRX

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Implants Diffusion International
UDI-DI code: 03662174014961
Reference / catalog number: H146

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Manufacturer information

Organization name: Implants Diffusion International
SRN: FR-MF-000000597
Manufacturer status: Active

Related devices

000403662174REUINSTRXOn the market 001403662174REUINSTRXOn the market 001603662174REUINSTRXOn the market 002503662174INSTRUL2On the market 003603662174REUINSTRXOn the market

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement		Still on market

Device identification

Trade name: H146
UDI-DI code: 03662174014961
Basic UDI-DI: 03662174REUINSTRX
Reference / catalog number: H146
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: Implant holder for guided surgery, IDBio and IDMax implant, Ø8 mm length 30 mm
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

L0399GENERAL SURGERY INSTRUMENTS, REUSABLE - 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

Certificates

Certificate health across this manufacturer's portfolio.

FR25/00000112Issued
Quality management systemNotified body: 1639Expiry: May 12, 2030