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PhotoFix Decellularized Bovine Pericardium
EUDAMEDClass III (EU MDR)
Ref PFP8X14-GModel PhotoFix Decellularized Bovine Pericardium
Identity
- Trade Name
- PhotoFix Decellularized Bovine Pericardium EUDAMED
- Device Name
- PhotoFix Decellularized Bovine Pericardium EUDAMED
- Model / Reference
- PhotoFix Decellularized Bovine Pericardium EUDAMEDPFP8X14-G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00877234001147 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 87723400PFP3L | Class III | Active |
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Manufacturer
- Manufacturer
- Artivion, Inc.
- EUDAMED SRN
- US-MF-000015763
- Authorised Representative
- JOTEC GmbH DE-AR-000006801
Sources (1)
- EUDAMED 33172df7-4ef2-4924-99a1-10826afa2fe0 61 fields · synced May 22, 2026