EUDAMED last updated this device on May 26, 2026

Bioripar - Bovine Pericardium Membrane

8033439BIORIPARBOVINOVN

On the marketClass III

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ASSUT EUROPE SPA
UDI-DI code: 08033439382135
Reference / catalog number: AEPB(F)120-202U

View device family (Basic UDI)

Role
Country
Date of registration
Address

EUDAMED last updated this device on May 26, 2026

Bioripar - Bovine Pericardium Membrane

8033439BIORIPARBOVINOVN

On the marketClass III

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ASSUT EUROPE SPA
UDI-DI code: 08033439382135
Reference / catalog number: AEPB(F)120-202U

View device family (Basic UDI)

Device identification

Trade name: Bioripar - Bovine Pericardium Membrane
UDI-DI code: 08033439382135
Basic UDI-DI: 8033439BIORIPARBOVINOVN
Reference / catalog number: AEPB(F)120-202U
Issuing entity: GS1

Classification

Risk category: Class III
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://www.assuteurope.com/public/eifu/71A_MDR_R6.pdf
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)08033439382135

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.

P900399TISSUE PATCHES - OTHER

Critical warnings

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

CW267
EUDAMED did not publish a description for this code.
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

Market distribution

Primary placement in Italy; available across 4 countries total.

Country	On market since	Until
ItalyPrimary placement		Still on market
EL		Still on market
Spain		Still on market
France		Still on market

Device identification

Trade name: Bioripar - Bovine Pericardium Membrane
UDI-DI code: 08033439382135
Basic UDI-DI: 8033439BIORIPARBOVINOVN
Reference / catalog number: AEPB(F)120-202U
Issuing entity: GS1

Classification

Risk category: Class III
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://www.assuteurope.com/public/eifu/71A_MDR_R6.pdf
Clinical sizes: No clinical sizes registered for this device.

Manufacturer information

Organization name: ASSUT EUROPE SPA
SRN: IT-MF-000018178
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08033439382135

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.

P900399TISSUE PATCHES - OTHER

Critical warnings

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

CW267
EUDAMED did not publish a description for this code.
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.

CSQ0013230524Supplemented
Quality management systemNotified body: 0373Expiry: Aug 7, 2028
CVD003124Issued
Technical documentationNotified body: 0373Expiry: Aug 7, 2028
CVD0030240124Supplemented
Technical documentationNotified body: 0373Expiry: Aug 7, 2028
CVD002023Issued
Technical documentationNotified body: 0373Expiry: Aug 7, 2028
CVD001423Issued
Technical documentationNotified body: 0373Expiry: Aug 7, 2028

Certificates covering this device

Market distribution

Primary placement in Italy; available across 4 countries total.

Country	On market since	Until
ItalyPrimary placement		Still on market
EL		Still on market
Spain		Still on market
France		Still on market

Bioripar - Bovine Pericardium Membrane

Bioripar - Bovine Pericardium Membrane

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

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

Certificates covering this device

Related devices