Identity
- Trade Name
- STERRAD™ Booster EUDAMED
- Device Name
- STERRAD™ Booster EUDAMED
- Model / Reference
- 15400-020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10705037016266 EUDAMED
- Basic UDI-DI
- 0705037A150000000000015QE EUDAMED
- Unit of Use DI
- 80705037016265 EUDAMED
- EMDN Code
- S900101 HYDROGEN PEROXIDE CARTRIDGES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
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
STERRAD™ Booster by Advanced Sterilization Products, Inc. — 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 | 0705037A150000000000015QE | Class IIa | Active |
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Manufacturer
- Manufacturer
- Advanced Sterilization Products, Inc.
- EUDAMED SRN
- US-MF-000008427
- Authorised Representative
- ASP, The Netherlands B.V. NL-AR-000002057
Sources (1)
- EUDAMED ed94e703-f256-4286-9505-5a2814bb3bf5 61 fields · synced Jun 19, 2026