Identity
- Trade Name
- ALPHATRIPART EUDAMEDFDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
- Device Name
- ALPHATRIPART MARYLAND DISSECTING FORCEPS EUDAMEDALPHATRIPART SCHERTL GRASPING FORCEPS Ø 5 MM, FENESTRATED LENGTH 360 MM, MONOPOLAR FDA UDI
- Model / Reference
- Z.0560.32 EUDAMEDZ.2935.32 FDA UDI
- Description
- ALPHATRIPART SCHERTL GRASPING FORCEPS Ø 5 MM, FENESTRATED LENGTH 360 MM, MONOPOLAR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049047111511 EUDAMED04049047113195 FDA UDI
- Basic UDI-DI
- B-04049047111511 EUDAMED
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- L180102 ENDOSCOPIC ELECTROSURGERY DISSECTORS, REUSABLE EUDAMED
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Alphatripart by Gimmi GmbH — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Gimmi GmbH
Sources (2)
- FDA UDI d044c95f-f67c-4650-b727-e971e9446221 34 fields · synced Sep 30, 2026
- EUDAMED 9761a92c-96e2-4f06-a8f0-b88e5671fe54 61 fields · synced Sep 17, 2026