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ImmunoCAP ISAC Starter Pack
EUDAMEDClass A (EU MDR)
Ref 81-1010-01
by Phadia AB
Identity
- Trade Name
- ImmunoCAP ISAC Starter Pack EUDAMED
- Device Name
- ImmunoCAP ISAC E112i EUDAMED
- Model / Reference
- 81-1010-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07333066021119 EUDAMED
- Basic UDI-DI
- 7333066BUDI0032LT EUDAMED
- EMDN Code
- W01029003 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Sweden 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
ImmunoCAP ISAC Starter Pack by Phadia AB — 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 | 7333066BUDI0032LT | Class A | Active |
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Manufacturer
- Manufacturer
- Phadia AB
- EUDAMED SRN
- SE-MF-000014170
Sources (1)
- EUDAMED 35e0fcff-2980-46ef-9de7-dbe94d5a7b36 61 fields · synced Jun 18, 2026