EUDAMED last updated this device on Sep 10, 2025

03.313.861

7611819a00013HR

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Synthes GmbH
UDI-DI code: 07612334224347
Reference / catalog number: 03.313.861

03.313.861 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Synthes GmbH. Placed on the EU market in Belgium. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Role
Country
Date of registration
Address

EUDAMED last updated this device on Sep 10, 2025

03.313.861

7611819a00013HR

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Synthes GmbH
UDI-DI code: 07612334224347
Reference / catalog number: 03.313.861

View device family (Basic UDI)

Device identification

Trade name: not provided
UDI-DI code: 07612334224347
Basic UDI-DI: 7611819a00013HR
Reference / catalog number: 03.313.861
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: MAXFRAME Mounting Pin, 5 Level High
Additional information URL: https://www.e-ifu.com/
Clinical sizes: See Additional Product Description

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)07612334224347

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.

P0912040102AXIAL BONE FIXATION SYSTEMS

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW026
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 Belgium; available across 32 countries total.

Country	On market since	Until
BelgiumPrimary placement		Still on market
Austria		Still on market
Bulgaria		Still on market
Cyprus		Still on market
Czechia		Still on market
Germany		Still on market
Denmark		Still on market
Estonia		Still on market
EL		Still on market
Spain		Still on market
Finland		Still on market
France		Still on market
Croatia		Still on market
Hungary		Still on market
Ireland		Still on market
Iceland		Still on market
Italy		Still on market
Liechtenstein		Still on market
Lithuania		Still on market
Luxembourg		Still on market
Latvia		Still on market
Malta		Still on market
Netherlands		Still on market
Norway		Still on market
Poland		Still on market
Portugal		Still on market
Romania		Still on market
Sweden		Still on market
Slovenia		Still on market
Slovakia		Still on market
Türkiye		Still on market
XI		Still on market

Device identification

Trade name: not provided
UDI-DI code: 07612334224347
Basic UDI-DI: 7611819a00013HR
Reference / catalog number: 03.313.861
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: MAXFRAME Mounting Pin, 5 Level High
Additional information URL: https://www.e-ifu.com/
Clinical sizes: See Additional Product Description

Manufacturer information

Organization name: Synthes GmbH
SRN: CH-MF-000013345
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)07612334224347

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.

P0912040102AXIAL BONE FIXATION SYSTEMS

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW026
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.

G70 056032 0143Issued
Technical documentationNotified body: 0123Expiry: Dec 19, 2029

Certificates covering this device

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

All products by Synthes GmbH

Market distribution

Primary placement in Belgium; available across 32 countries total.

Country	On market since	Until
BelgiumPrimary placement		Still on market
Austria		Still on market
Bulgaria		Still on market
Cyprus		Still on market
Czechia		Still on market
Germany		Still on market
Denmark		Still on market
Estonia		Still on market
EL		Still on market
Spain		Still on market
Finland		Still on market
France		Still on market
Croatia		Still on market
Hungary		Still on market
Ireland		Still on market
Iceland		Still on market
Italy		Still on market
Liechtenstein		Still on market
Lithuania		Still on market
Luxembourg		Still on market
Latvia		Still on market
Malta		Still on market
Netherlands		Still on market
Norway		Still on market
Poland		Still on market
Portugal		Still on market
Romania		Still on market
Sweden		Still on market
Slovenia		Still on market
Slovakia		Still on market
Türkiye		Still on market
XI		Still on market

03.313.861

03.313.861

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