Identity
- Trade Name
- exGraft E20P EUDAMED
- Device Name
- exGraft E20P EUDAMED
- Model / Reference
- REX052503 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00818136021451 EUDAMED
- Basic UDI-DI
- B-00818136021451 EUDAMED
- EMDN Code
- P070102020101 PTFE VASCULAR PROSTHESES, STRAIGHT, SIMPLE EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
exGraft E20P by Peca Labs, Inc. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00818136021451 | Class III | Active |
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Manufacturer
- Manufacturer
- PECA Labs, Inc.
- EUDAMED SRN
- US-MF-000021432
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED a1dd35ff-ff27-4353-b232-db679e5c1d27 61 fields · synced Jul 12, 2026