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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

Insert XLfit céramique composite… — Class III MDR

MD Atlas
PROTHEOS INDUSTRIE

EUDAMED last updated this device on Jan 4, 2023

Insert XLfit céramique composite Ø 36 mm (ZZ)

++EPRS16030000BUP

On the marketClass III

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: PROTHEOS INDUSTRIE
UDI-DI code: EPRS160336ZZB0
Reference / catalog number: 16-03-36-ZZ

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Manufacturer information

Organization name: PROTHEOS INDUSTRIE
SRN: FR-MF-000000150
Manufacturer status: Active

Related devices

Cotyle XLfit non cimenté diam. 32/46 mmB-EPRS15033246A0On the market Cotyle XLfit non cimenté diam. 32/48 mmB-EPRS15033248A0On the market Cotyle XLfit non cimenté diam. 36/50 mmB-EPRS15033650A0On the market Cotyle XLfit non cimenté diam. 36/52 mmB-EPRS15033652A0On the market Cotyle XLfit non cimenté diam. 36/54 mmB-EPRS15033654A0On the market

Critical warnings

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

CW009
EUDAMED did not publish a description for this code.
CW001
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW011
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW026
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	Jun 13, 2013	Still on market

Device identification

Trade name: Insert XLfit céramique composite Ø 36 mm (ZZ)
UDI-DI code: EPRS160336ZZB0
Basic UDI-DI: ++EPRS16030000BUP
Reference / catalog number: 16-03-36-ZZ
Issuing entity: HIBCC

Classification

Risk category: Class III
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)

P0908030402HIP PROSTHESES CERAMIC ACETABULAR INSERTS

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.

39976Issued
Technical documentationNotified body: 0459Expiry: Aug 27, 2029
39444Issued
Technical documentationNotified body: 0459Expiry: Oct 22, 2028
39978Issued
Technical documentationNotified body: 0459Expiry: Aug 27, 2029
39411Issued
Technical documentationNotified body: 0459Expiry: Sep 20, 2028
39412Issued
Quality management systemNotified body: 0459Expiry: Oct 13, 2027
39169

Issued

Quality management systemNotified body: 0459Expiry: Oct 13, 2027