Identity
- Trade Name
- DISKOM EUDAMED
- Device Name
- DISCECTOMY SYSTEMS EUDAMED
- Model / Reference
- DKR1716CD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860018368 EUDAMED
- Basic UDI-DI
- 8033860DISCFT01D77 EUDAMED
- EMDN Code
- A01020102 ASPIRATION FINE NEEDLES AND KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
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
Diskom by Biopsybell Srl — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180315 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8033860DISCFT01D77 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
- FDA Applicant
- Biopsybell S.R.L.
Sources (2)
- EUDAMED 77fcef88-4c2b-4d12-8dd0-eb1e028d6da3 85 fields · synced Jun 18, 2026
- FDA 510(k) K180315 1 fields · synced May 18, 2026