Identity
- Trade Name
- Activa Instrument EUDAMEDDepth gauge, for cannulated screws EUDAMED
- Device Name
- Depth gauge, for cannulated screws EUDAMEDDepth Gauge EUDAMED
- Model / Reference
- B-ISC-9020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438394005266 EUDAMED
- Basic UDI-DI
- B-06438394005266 EUDAMED6438394INS008WU EUDAMED
- Direct Marketing DI
- 06438394005266 EUDAMED
- EMDN Code
- L098099 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland 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
Activa Instrument by Bioretec Ltd. — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06438394005266 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06438394005266 | Class I | Active |
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Manufacturer
- Manufacturer
- Bioretec Ltd.
- EUDAMED SRN
- FI-MF-000001328
Sources (2)
- EUDAMED c7cdd1c3-8abd-46a5-98bf-7a70fcda8a16 61 fields · synced Jul 16, 2026
- EUDAMED e3597020-29d6-4810-9284-b6140cf4b785 61 fields · synced May 17, 2026