Identity
- Trade Name
- PCEA Syringe Sets EUDAMED
- Device Name
- PCEA Syringe Set EUDAMED
- Model / Reference
- 2P3334 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00085412653518 EUDAMED
- Basic UDI-DI
- 00854120000000000000118JA EUDAMED
- EMDN Code
- A03040199 INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
PCEA Syringe Sets by Baxter Healthcare SA — 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 | 00854120000000000000118JA | Class IIa | Active |
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Manufacturer
- Manufacturer
- Baxter Healthcare SA
- EUDAMED SRN
- CH-MF-000026124
- Authorised Representative
- Baxter Deutschland GmbH DE-AR-000010308
Sources (1)
- EUDAMED a9bed1dd-ba6b-4585-bfa5-fb30091eca13 61 fields · synced Jun 19, 2026