Identity
- Trade Name
- GSTK Box EUDAMED
- Model / Reference
- Accessories EUDAMED65002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290117810835 EUDAMED
- Basic UDI-DI
- 72901178AccYW EUDAMED
- Direct Marketing DI
- 07290117810835 EUDAMED
- EMDN Code
- L0318 INSTRUMENTS FOR SUPPORT OF SURGICAL DEVICES, REUSABLE 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
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
GSTK Box 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 | 72901178AccYW | 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 354721cc-deb8-499a-a3f6-3e281e384be5 61 fields · synced Jul 21, 2026
- EUDAMED 96cb5a7e-234c-4c6c-accb-afe2d191d587 61 fields · synced Jul 21, 2026