Identity
- Trade Name
- PEEL-AWAY Introducer 4.5FR x 5cm EUDAMED
- Device Name
- PEEL-AWAY Introducer EUDAMED
- Model / Reference
- 201.60.63.45V EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056459676404 EUDAMED
- Basic UDI-DI
- 805645967peel2Z EUDAMED
- EMDN Code
- C0503 CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
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
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
PEEL-AWAY Introducer 4.5FR x 5cm by PLAN 1 HEALTH S.r.l. — Class IIa — 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 | 805645967peel2Z | Class IIa | Active |
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Manufacturer
- Manufacturer
- PLAN 1 HEALTH S.r.l.
- EUDAMED SRN
- IT-MF-000022746
Sources (1)
- EUDAMED 3443736c-f2fb-4e54-97aa-66c60f4c975a 61 fields · synced Jul 11, 2026