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AlphaLoC Block Out Spacer
EUDAMEDClass I (EU MDR)
Ref 4883Model Overdenture Tools
Identity
- Trade Name
- AlphaLoC Block Out Spacer EUDAMED
- Model / Reference
- Overdenture Tools EUDAMED4883 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290117817896 EUDAMED
- Basic UDI-DI
- 72901178Over43 EUDAMED
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
EUDAMEDEUDAMED
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
AlphaLoC Block Out Spacer by Alpha Bio Tec Ltd. — 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 | 72901178Over43 | Class I | Active |
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Manufacturer
- Manufacturer
- Alpha Bio Tec Ltd.
- EUDAMED SRN
- IL-MF-000021145
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (2)
- EUDAMED 63e6148f-690d-4ddd-a292-cb1628b3634c 61 fields · synced Jul 8, 2026
- EUDAMED bfedc42e-8101-4a11-8822-fc758b293637 61 fields · synced Jun 19, 2026