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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

DIAM, 10mm Template — Class I MDR by Companion Spine France…

MD Atlas
Companion Spine France SAS

EUDAMED last updated this device on Jan 31, 2024

DIAM, 10mm Template

37015213FDMN00044X

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Companion Spine France SAS
UDI-DI code: 03701521300071
Reference / catalog number: CS001B0010

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Manufacturer information

Organization name: Companion Spine France SAS
SRN: FR-MF-000013875
Manufacturer status: Active

Critical warnings

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

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

Market distribution

Primary placement in France; available across 1 country total.

Placed on the market in France; per-country availability dates not published.

Device identification

Trade name: DIAM, 10mm Template
UDI-DI code: 03701521300071
Basic UDI-DI: 37015213FDMN00044X
Reference / catalog number: CS001B0010
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

L091199ORTHOPAEDIC PROSTHETICS 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

Related devices

DIAM, 12mm Template37015213FDMN00044XOn the market DIAM, 14mm Template37015213FDMN00044XOn the market DIAM, 8mm Template37015213FDMN00044XOn the market DIAM, Implant Inserter37015213FDMN00034VOn the market DIAM, Outer Case37015213FDMN00104SOn 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.