Identity
- Trade Name
- PoinSetter EUDAMEDPoint Setter FDA UDI
- Generic Name
- Surgical instrument assist arm system, power-adjusted FDA UDI
- Device Name
- PoinSetter EUDAMEDThe Pointsetter is indicated for use as a holder for an endoscope FDA UDI
- Model / Reference
- PSMS-2 EUDAMEDFDA UDI
- Description
- The Pointsetter is indicated for use as a holder for an endoscope FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04589698450015 EUDAMEDFDA UDI
- Basic UDI-DI
- 458969845001PN EUDAMED
- Direct Marketing DI
- 04589698450015 EUDAMED
- FDA Product Code
- GWG FDA UDIGCJ FDA UDI
- EMDN Code
- Z12029099 VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI–INVASIVE SURGERY – OTHER EUDAMED
- GMDN Term
- Surgical instrument assist arm system, power-adjusted FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1480 FDA UDI876.1500 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
PoinSetter by Mitaka Kohki Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 458969845001PN | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Mitaka Kohki Co., Ltd.
- EUDAMED SRN
- JP-MF-000013028
- Authorised Representative
- Mitaka Europe GmbH DE-AR-000006361
Sources (2)
- EUDAMED 499f4ad9-8f3c-4234-a45f-577437ca6f06 61 fields · synced Aug 4, 2026
- FDA UDI 39fb9498-b9e3-4a80-b99f-2bd2da6a8653 33 fields · synced May 30, 2026