Identity
- Trade Name
- SteriPlas Sensor Module EUDAMED
- Device Name
- SteriPlas Sensor Module EUDAMED
- Model / Reference
- ARPP-SP-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060758510027 EUDAMED
- Basic UDI-DI
- 506075851SSMKT EUDAMED
- EMDN Code
- Z12040285 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
SteriPlas Sensor Module by Adtec Healthcare Limited — Class I — 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 | 506075851SSMKT | Class I | Active |
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Manufacturer
- Manufacturer
- Adtec Healthcare Limited
- EUDAMED SRN
- GB-MF-000002105
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (1)
- EUDAMED 0ff1a649-4eee-49f4-ad83-d822efc9a3eb 61 fields · synced Jun 19, 2026