EUDAMED last updated this device on Jun 10, 2022

Combo Plus

B-08717853297465

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: OrbusNeich Medical, B.V.
UDI-DI code: 08717853297465
Reference / catalog number: 230-152-11

Combo Plus is an MDD-legacy medical device registered in EUDAMED. It is classified as Class III. Manufactured by OrbusNeich Medical, B.V.. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Role
Country
Date of registration
Address

EUDAMED last updated this device on Jun 10, 2022

Combo Plus

B-08717853297465

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: OrbusNeich Medical, B.V.
UDI-DI code: 08717853297465
Reference / catalog number: 230-152-11

View device family (Basic UDI)

Device identification

Trade name: Combo Plus
UDI-DI code: 08717853297465
Basic UDI-DI: B-08717853297465
Reference / catalog number: 230-152-11
Issuing entity: GS1

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: The COMBO Plus Stent is a coronary balloon expandable vascular prosthesis. The COMBO Plus Stent consists of a 316L stainless steel alloy coated with a biocompatible, biodegradable polymer containing sirolimus (also known as rapamycin). Covalently attached to this matrix is a layer of murine, monoclonal, anti-human CD34 antibody. The antibody specifically targets CD34+ cells in circulation. Endothelial progenitor cells (EPCs) are CD34+. This stent is supplied premounted on a delivery catheter.
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)08717853297465

EMDN nomenclature code(s)

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

P0704020102COATED CORONARY STENTS

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 Netherlands; available across 21 countries total.

Country	On market since	Until
NetherlandsPrimary placement	Aug 1, 2016	Still on market
Belgium	Jan 1, 2017	Still on market
Bulgaria	Apr 1, 2017	Still on market
Cyprus	Dec 2, 2016	Still on market
Czechia	Apr 1, 2017	Still on market
Germany	Apr 1, 2017	Still on market
Denmark	Jan 1, 2017	Still on market
Estonia	Jan 1, 2019	Still on market
EL	Apr 1, 2017	Still on market
Spain	Jan 1, 2017	Still on market
France	Sep 1, 2019	Still on market
Italy	Jan 1, 2017	Still on market
Lithuania	Jun 1, 2017	Still on market
Latvia	Apr 1, 2017	Still on market
Poland	May 19, 2017	Still on market
Portugal	Jun 1, 2020	Still on market
Romania	Mar 1, 2017	Still on market
Sweden	Jan 1, 2019	Still on market
Slovenia	Apr 1, 2017	Still on market
Slovakia	Mar 7, 2017	Still on market
Türkiye	Apr 1, 2017	Still on market

Device identification

Trade name: Combo Plus
UDI-DI code: 08717853297465
Basic UDI-DI: B-08717853297465
Reference / catalog number: 230-152-11
Issuing entity: GS1

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: The COMBO Plus Stent is a coronary balloon expandable vascular prosthesis. The COMBO Plus Stent consists of a 316L stainless steel alloy coated with a biocompatible, biodegradable polymer containing sirolimus (also known as rapamycin). Covalently attached to this matrix is a layer of murine, monoclonal, anti-human CD34 antibody. The antibody specifically targets CD34+ cells in circulation. Endothelial progenitor cells (EPCs) are CD34+. This stent is supplied premounted on a delivery catheter.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

Manufacturer information

Organization name: OrbusNeich Medical, B.V.
SRN: NL-MF-000010907
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08717853297465

EMDN nomenclature code(s)

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

P0704020102COATED CORONARY STENTS

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

No certificates registered for this manufacturer.

Legacy certificates

Certificate number: CE 649589
Type: MDD Annex II §4
Notified body: BSI Group The Netherlands B.V. (2797)
Validity: May 26, 2024

Certificates covering this device

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

All products by OrbusNeich Medical, B.V.

Market distribution

Primary placement in Netherlands; available across 21 countries total.

Country	On market since	Until
NetherlandsPrimary placement	Aug 1, 2016	Still on market
Belgium	Jan 1, 2017	Still on market
Bulgaria	Apr 1, 2017	Still on market
Cyprus	Dec 2, 2016	Still on market
Czechia	Apr 1, 2017	Still on market
Germany	Apr 1, 2017	Still on market
Denmark	Jan 1, 2017	Still on market
Estonia	Jan 1, 2019	Still on market
EL	Apr 1, 2017	Still on market
Spain	Jan 1, 2017	Still on market
France	Sep 1, 2019	Still on market
Italy	Jan 1, 2017	Still on market
Lithuania	Jun 1, 2017	Still on market
Latvia	Apr 1, 2017	Still on market
Poland	May 19, 2017	Still on market
Portugal	Jun 1, 2020	Still on market
Romania	Mar 1, 2017	Still on market
Sweden	Jan 1, 2019	Still on market
Slovenia	Apr 1, 2017	Still on market
Slovakia	Mar 7, 2017	Still on market
Türkiye	Apr 1, 2017	Still on market

Combo Plus

Combo Plus

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

Legacy certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

Legacy certificates

Related devices