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Piccolo Xpress
EUDAMEDClass A (EU MDR)
Ref 1100-0000ERModel 1100-1001R
by Abaxis, Inc.
Identity
- Trade Name
- Piccolo Xpress EUDAMED
- Device Name
- Piccolo Xpress chemistry analyzer, recertified EUDAMED
- Model / Reference
- 1100-1001R EUDAMED1100-0000ER EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EABA11000000ER1 EUDAMED
- Basic UDI-DI
- ++EABA11000000ER5X EUDAMED
- Direct Marketing DI
- +EABA11000000ER0 EUDAMED
- EMDN Code
- W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Piccolo Xpress by Abaxis, Inc. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | ++EABA11000000ER5X | Class A | Active |
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Manufacturer
- Manufacturer
- Abaxis, Inc.
- EUDAMED SRN
- US-MF-000021651
- Authorised Representative
- ABAXIS Europe GmbH DE-AR-000017984
Sources (1)
- EUDAMED 0787750a-4236-487d-8453-4179b2dc8549 61 fields · synced May 22, 2026