Identity
- Trade Name
- PHANTOM ML ACMI ADAPTER EUDAMEDStryker FDA UDI
- Generic Name
- Light source adaptor FDA UDI
- Device Name
- Adapter EUDAMEDLIGHT CABLE ADAPTER FDA UDI
- Model / Reference
- 48851313B EUDAMEDFDA UDI
- Description
- LIGHT CABLE ADAPTER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843059104424 EUDAMEDFDA UDI
- Basic UDI-DI
- 8430591ADAPTERRH EUDAMED
- Direct Marketing DI
- 00843059104424 EUDAMED
- FDA Product Code
- FDG FDA UDI
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMED
- GMDN Term
- Light source adaptor FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.4530 FDA UDI
- Market of Registration
- Austria 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
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Endoscopic light source unit, line-powered
Phantom Ml Acmi Adapter by TeDan Surgical Innovations, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8430591ADAPTERRH | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- TeDan Surgical Innovations, Inc.
- EUDAMED SRN
- US-MF-000016933
- Authorised Representative
- TeDan Surgical Innovations B.V. NL-AR-000002696
Sources (2)
- EUDAMED d314a522-277b-4114-97a0-f7fba76a6821 61 fields · synced Sep 18, 2026
- FDA UDI 03399ded-fdd6-41de-b5ce-28f07f3682ae 33 fields · synced May 30, 2026