Identity
- Trade Name
- SmartDose EUDAMED
- Device Name
- SmartDose On-Body Delivery System (1.2mL) EUDAMED
- Model / Reference
- 100012369 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850022888014 EUDAMED
- Basic UDI-DI
- 0850228881000112504W 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
SmartDose by West Pharmaceutical Services AZ, 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 | 0850228881000112504W | Class IIa | Active |
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Manufacturer
- Manufacturer
- West Pharmaceutical Services AZ, Inc.
- EUDAMED SRN
- US-MF-000020637
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 291a443b-6cc4-4c65-a2fa-89108ce5920d 61 fields · synced Jun 17, 2026