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0me1915
EUDAMEDClass IIa (EU MDR)
Ref 0ME1915Model Ago monouso per agoaspirazione
Identity
- Trade Name
- 0ME1915 EUDAMED
- Device Name
- Ago monouso Chiba per aspirati citologici EUDAMED
- Model / Reference
- Ago monouso per agoaspirazione EUDAMED0ME1915 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053670914391 EUDAMED
- Basic UDI-DI
- B-08053670914391 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Diskectomy system, percutaneous, automatic
0me1915 by Biomedical S.r.l. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Diskectomy system, percutaneous, automatic.
- Biopsy Needle — Argon Medical Devices, Inc. · Class IIa
- INTRODUTTORE — BIOPSYBELL SRL · Class IIa
- CHIBELL CON SIRINGA — BIOPSYBELL SRL · Class IIa
- CHIBELL — BIOPSYBELL SRL · Class IIa
- Biopsy Needle — Argon Medical Devices, Inc. · Class IIa
- DISKIT — BIOPSYBELL SRL · Class IIa
- CHIBELL — BIOPSYBELL SRL · Class IIa
- CHIBELL — BIOPSYBELL SRL · Class IIa
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08053670914391 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biomedical S.r.l.
- EUDAMED SRN
- IT-MF-000027821
Sources (1)
- EUDAMED 4786ec0a-e973-461f-9d60-696f2c33abbc 61 fields · synced Jul 12, 2026