Identity
- Trade Name
- Adtec SteriPlas EUDAMED
- Device Name
- SteriPlas EUDAMED
- Model / Reference
- ARPP-SP2-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060758510010 EUDAMED
- Basic UDI-DI
- 506075851NTGPDR EUDAMEDB-05060758510010 EUDAMED
- Direct Marketing DI
- 05060758510010 EUDAMED
- EMDN Code
- Z12040299 GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Austria EUDAMEDNorthern Ireland 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
Category: Dermatological laser beam guiding handpiece
SteriPlas by Adtec Healthcare Limited — Class IIb — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 506075851NTGPDR | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 506075851NTGPDR | Class IIb | Active |
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Manufacturer
- Manufacturer
- Adtec Healthcare Limited
- EUDAMED SRN
- GB-MF-000002105
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED 50ea3951-4707-40bb-838d-b1162e92afc5 61 fields · synced Jul 29, 2026
- EUDAMED 62224a55-dcd9-4ccc-9cda-af8756e0b6cb 61 fields · synced May 16, 2026