EUDAMED last updated this device on Feb 17, 2023

G3

B-M614G31

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: EUROSPINE SARL
UDI-DI code: M614G31
Reference / catalog number: G3

View device family (Basic UDI)

Role
Country
Date of registration
Address

EUDAMED last updated this device on Feb 17, 2023

G3

B-M614G31

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: EUROSPINE SARL
UDI-DI code: M614G31
Reference / catalog number: G3

View device family (Basic UDI)

Device identification

Trade name: not provided
UDI-DI code: M614G31
Basic UDI-DI: B-M614G31
Reference / catalog number: G3
Issuing entity: HIBCC

Classification

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

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://eurospine.com/
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

M614G31

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

By subscribing you accept the Privacy Policy.

EMDN nomenclature code(s)

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

L1199NEUROSURGERY 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 6 countries total.

Country	On market since	Until
FrancePrimary placement		Still on market
Austria		Still on market
Germany		Still on market
EL		Still on market
Spain		Still on market
Romania		Still on market

Device identification

Trade name: not provided
UDI-DI code: M614G31
Basic UDI-DI: B-M614G31
Reference / catalog number: G3
Issuing entity: HIBCC

Classification

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

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://eurospine.com/
Clinical sizes: No clinical sizes registered for this device.

Manufacturer information

Organization name: EUROSPINE SARL
SRN: FR-MF-000001820
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

M614G31

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

By subscribing you accept the Privacy Policy.

EMDN nomenclature code(s)

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

L1199NEUROSURGERY 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.

FR25/00000203Issued
Quality management systemNotified body: 1639Expiry: Nov 4, 2030

Certificates covering this device

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

Market distribution

Primary placement in France; available across 6 countries total.

Country	On market since	Until
FrancePrimary placement		Still on market
Austria		Still on market
Germany		Still on market
EL		Still on market
Spain		Still on market
Romania		Still on market

G3

G3

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI 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

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