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PhotoFix Decellularized Bovine Pericardium

EUDAMED

Class III (EU MDR)

Ref PFP1X10-GModel PhotoFix Decellularized Bovine PericardiumRef PFP4X4-GRef PFP2X9-GRef PFP0.8X8-G

by Artivion, Inc.

Identity

Trade Name
PhotoFix Decellularized Bovine Pericardium EUDAMED
Device Name
PhotoFix Decellularized Bovine Pericardium EUDAMED
Model / Reference
PhotoFix Decellularized Bovine Pericardium EUDAMED
PFP1X10-G EUDAMED
PFP4X4-G EUDAMED
PFP2X9-G EUDAMED
PFP0.8X8-G EUDAMED

Identifiers

Primary DI / UDI-DI
00877234001161 EUDAMED
00877234001123 EUDAMED
00877234001154 EUDAMED
00877234001116 EUDAMED
Basic UDI-DI
87723400PFP3L EUDAMED
EMDN Code
P900399 TISSUE PATCHES - OTHER EUDAMED

Classification

Device Class
Class III EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

Yes

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

PhotoFix Decellularized Bovine Pericardium by Artivion, Inc. — Class III — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Artivion, Inc.
EUDAMED SRN
US-MF-000015763
Authorised Representative
JOTEC GmbH DE-AR-000006801

Sources (4)

  • EUDAMED 2afe7c89-6650-4c01-abe0-fed884014df5 61 fields · synced Jul 26, 2026
  • EUDAMED a0f301fb-8218-4c0d-ac44-673ee2f989af 61 fields · synced May 18, 2026
  • EUDAMED 33e21858-45c8-40c9-8d68-1cdbd43ea3aa 61 fields · synced May 18, 2026
  • EUDAMED 55035a18-5f2b-4ad5-95d6-e1d08f1f93e2 61 fields · synced May 18, 2026