Identity
- Trade Name
- SteriPlas Sensor Module EUDAMED
- Device Name
- SteriPlas Sensor Module EUDAMED
- Model / Reference
- SM01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060758510034 EUDAMED
- Basic UDI-DI
- B-05060758510034 EUDAMED
- EMDN Code
- Z12040285 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
SteriPlas Sensor Module by Adtec Healthcare Limited — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05060758510034 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Adtec Healthcare Limited
- EUDAMED SRN
- GB-MF-000002105
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED d35d0545-9100-40d5-84c7-15c529f29319 61 fields · synced Jun 18, 2026