EUDAMED last updated this device on Jan 12, 2024

JUST UNIC®

376025538L09112ASA

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: EVOLUTIS
UDI-DI code: 03701271024883
Reference / catalog number: E28 T240

View device family (Basic UDI)

Role
Country
Date of registration
Address

EUDAMED last updated this device on Jan 12, 2024

JUST UNIC®

376025538L09112ASA

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: EVOLUTIS
UDI-DI code: 03701271024883
Reference / catalog number: E28 T240

View device family (Basic UDI)

Device identification

Trade name: JUST UNIC®
UDI-DI code: 03701271024883
Basic UDI-DI: 376025538L09112ASA
Reference / catalog number: E28 T240
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: Off-set Humeral head Ø40 Just Unic
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)03701271024883

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

L091199ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

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

Certificates covering this device

No certificate specifically references this device's Basic UDI-DI.

Market distribution

Primary placement in France; available across 3 countries total.

Country	On market since	Until
FrancePrimary placement		Still on market
Germany		Still on market
Portugal		Still on market

Device identification

Trade name: JUST UNIC®
UDI-DI code: 03701271024883
Basic UDI-DI: 376025538L09112ASA
Reference / catalog number: E28 T240
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: Off-set Humeral head Ø40 Just Unic
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

Manufacturer information

Organization name: EVOLUTIS
SRN: FR-MF-000000492
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)03701271024883

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

L091199ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

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

Certificates

Certificate health across this manufacturer's portfolio.

016-00-04-MDRSupplemented
Quality management systemNotified body: 0426Expiry: Apr 5, 2028
074-00-00-MDRWithdrawn
Quality management systemNotified body: 0426Expiry: Apr 21, 2030
055-00-00-MDRIssued
Technical documentationNotified body: 0426Expiry: Sep 11, 2029
017-00-00-MDRIssued
Technical documentationNotified body: 0426Expiry: Apr 5, 2028

Certificates covering this device

No certificate specifically references this device's Basic UDI-DI.

Market distribution

Primary placement in France; available across 3 countries total.

Country	On market since	Until
FrancePrimary placement		Still on market
Germany		Still on market
Portugal		Still on market

JUST UNIC®

JUST UNIC®

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Substances

Regulatory

Lifecycle

Certificates covering this device

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Substances

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

Related devices