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EasyCut
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref PC01915Ref PC01709Ref PC02015Ref PC01910Ref PC02010Ref PC02120Ref PC01610Ref PC02005Ref PC01715Ref PC02110
Identity
- Trade Name
- EasyCut EUDAMEDFDA UDI
- Generic Name
- Body aspiration needle, single-use FDA UDI
- Device Name
- EasyCut EUDAMEDDISPOSABLE SEMIAUTOMATIC NEEDLE 16G X 100 mm FOR CYTO-HISTOLOGICAL BIOPSY ASPIRATION AS FOR MENGHINI MODIFIED FDA UDI
- Model / Reference
- PC01915 EUDAMEDPC01709 EUDAMEDPC02015 EUDAMEDPC01910 EUDAMEDPC02010 EUDAMEDPC02120 EUDAMEDPC01610 EUDAMEDFDA UDIPC02005 EUDAMEDPC01715 EUDAMEDPC02110 EUDAMED
- Description
- DISPOSABLE SEMIAUTOMATIC NEEDLE 16G X 100 mm FOR CYTO-HISTOLOGICAL BIOPSY ASPIRATION AS FOR MENGHINI MODIFIED FDA UDI
Identifiers
- Catalog Number
- PC01610 FDA UDI
- Primary DI / UDI-DI
- 08052440105533 EUDAMED08032986356996 EUDAMED08052440105632 EUDAMED08052440105472 EUDAMED08052440105625 EUDAMED08032986357313 EUDAMED08052440105502 EUDAMEDFDA UDI08052440103133 EUDAMED08052440105564 EUDAMED08052440105489 EUDAMED
- Basic UDI-DI
- B-08052440105533 EUDAMEDB-08032986356996 EUDAMEDB-08052440105632 EUDAMEDB-08052440105472 EUDAMEDB-08052440105625 EUDAMEDB-08032986357313 EUDAMEDB-08052440105502 EUDAMEDB-08052440103133 EUDAMEDB-08052440105564 EUDAMEDB-08052440105489 EUDAMED
- 510(k) Number
- K160316 FDA UDI
- FDA Product Code
- FCG FDA UDIKNW FDA UDI
- EMDN Code
- A0102010101 SHEARING BIOPSY NEEDLES EUDAMED
- GMDN Term
- Body aspiration needle, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
EasyCut by M.d.l. S.r.l. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08052440105533 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- M.D.L. S.r.l.
- EUDAMED SRN
- IT-MF-000011599
Sources (11)
- EUDAMED 27f5c456-8e29-4db3-9cd8-884a79b00781 61 fields · synced Oct 6, 2026
- EUDAMED f3361048-30ff-44b1-a242-ec027d625e0b 61 fields · synced May 17, 2026
- EUDAMED 95acc00b-7740-44ba-9e15-a735e5556377 61 fields · synced May 17, 2026
- EUDAMED 115ec6bc-f579-4df0-a62a-2faa60ed8074 61 fields · synced May 17, 2026
- EUDAMED b6e7b4ce-2677-4396-9e1a-fd11718fbba8 61 fields · synced May 17, 2026
- EUDAMED d2e02e71-21fc-40e2-92b3-01322d740f08 61 fields · synced May 18, 2026
- EUDAMED fbf0e4cf-10ac-4a29-aab1-8c354729a2c2 61 fields · synced May 18, 2026
- EUDAMED d4b55837-40f3-4590-8c9c-b0073ece7cae 61 fields · synced May 18, 2026
- EUDAMED f2cc7b48-1923-4ab8-b3f1-c70f27fdef60 61 fields · synced May 18, 2026
- EUDAMED 0a254026-bdbe-424b-879c-0c74fa0aa5b8 61 fields · synced May 18, 2026
- FDA UDI ddc009fe-0830-4233-9071-f921282ba744 36 fields · synced May 30, 2026