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

Insert XLmob polyéthylène Ø28/58 mm — Class III MDD

MD Atlas
PROTHEOS INDUSTRIE

EUDAMED last updated this device on Jan 28, 2026

Insert XLmob polyéthylène Ø28/58 mm

B-EPRS16082858A0

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: PROTHEOS INDUSTRIE
UDI-DI code: EPRS16082858A0
Reference / catalog number: 16-08-28-58

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: 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	Feb 27, 2017	Still on market

Device identification

Trade name: Insert XLmob polyéthylène Ø28/58 mm
UDI-DI code: EPRS16082858A0
Basic UDI-DI: B-EPRS16082858A0
Reference / catalog number: 16-08-28-58
Issuing entity: HIBCC

Classification

Risk category: Class III
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Composant acétabulaire de prothèse de hanche
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

P0908030502DOUBLE-MOBILITY ACETABULAR COMPONENTS 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
39169Issued
Quality management systemNotified body: 0459Expiry: Oct 13, 2027