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Moon
EUDAMEDClass IIa (EU MDR)
Ref MN2209ECRef MN2112LECRef MN2110ECRef MNC1608ECRef MN2005LECRef MN2011ECRef MNC2009Ref MN2105LECRef MN1815ECRef MN2111ECRef MN1812LECRef MN2007.5ECRef MN2009LRef MN2111LECRef MN2107EC
Identity
- Trade Name
- MOON EUDAMED
- Device Name
- NEEDLES FOR BIOPSY OR EXPLANT EUDAMEDMOON EUDAMED
- Model / Reference
- MN2209EC EUDAMEDMN2112LEC EUDAMEDMN2110EC EUDAMEDMNC1608EC EUDAMEDMN2005LEC EUDAMEDMN2011EC EUDAMEDMNC2009 EUDAMEDMN2105LEC EUDAMEDMN1815EC EUDAMEDMN2111EC EUDAMEDMN1812LEC EUDAMEDMN2007.5EC EUDAMEDMN2009L EUDAMEDMN2111LEC EUDAMEDMN2107EC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033860045876 EUDAMED08033860013271 EUDAMED08033860024802 EUDAMED08033860025618 EUDAMED08033860045074 EUDAMED08033860044978 EUDAMED08033860039332 EUDAMED08033860045098 EUDAMED08033860005153 EUDAMED08033860044992 EUDAMED08033860016630 EUDAMED08033860003623 EUDAMED08033860012113 EUDAMED08033860045036 EUDAMED08033860045050 EUDAMED
- Basic UDI-DI
- 8033860BIOEFT01U5 EUDAMEDB-08033860024802 EUDAMED
- EMDN Code
- A019012 BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS 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
Moon by Biopsybell Srl — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 8033860BIOEFT01U5 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8033860BIOEFT01U5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (16)
- EUDAMED 21a3dff0-c80b-4dd4-b3fc-0df76c862e7f 61 fields · synced Aug 3, 2026
- EUDAMED 90fca6b2-bce8-45ec-b370-20075f90786e 61 fields · synced May 17, 2026
- EUDAMED 7fd62fcd-de5f-4465-94cd-60e1241940fb 61 fields · synced May 17, 2026
- EUDAMED 5736fcaf-fd52-440d-ad4f-ab811be52a64 61 fields · synced May 17, 2026
- EUDAMED 954ad75c-acef-438a-9cab-1c3fe9bf2dd2 61 fields · synced May 17, 2026
- EUDAMED d2226f2f-a2cf-4858-8b6f-088d98e75b7b 61 fields · synced May 17, 2026
- EUDAMED fb1c3578-f260-4174-b0ef-cee4ffab6880 61 fields · synced May 18, 2026
- EUDAMED e2410b24-b8c0-4d51-872a-2aeb3a862479 61 fields · synced May 18, 2026
- EUDAMED 426284a5-7600-4363-84dd-1ad8fbbcc35e 61 fields · synced May 18, 2026
- EUDAMED a1c87c5f-f142-4a0d-8a9f-095cd5e18fc8 61 fields · synced May 18, 2026
- EUDAMED 628d64fc-2ed8-4b2f-9cf2-7af4f202b095 61 fields · synced May 18, 2026
- EUDAMED 9e91bfdc-7a9c-43f9-a3ba-e116bbf366e0 61 fields · synced May 18, 2026
- EUDAMED 40c42a03-4615-48a7-ae3a-f60d66efc6d7 61 fields · synced May 18, 2026
- EUDAMED 0e7807e6-98b5-457f-a6b7-9f92b6bbfa17 61 fields · synced May 19, 2026
- EUDAMED 35247515-7f88-48ef-9229-f644621b29af 61 fields · synced May 19, 2026
- EUDAMED 73d8950f-4862-4205-b7d4-f1ee1c4d5b5c 61 fields · synced Jul 9, 2026