Identity
- Trade Name
- ACMI Adapter EUDAMEDTSI FDA UDI
- Generic Name
- Light source adaptor FDA UDI
- Device Name
- Adapter EUDAMEDACMI ADAPTER FDA UDI
- Model / Reference
- ML-0053 EUDAMEDFDA UDI
- Description
- ACMI ADAPTER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843059112368 EUDAMEDFDA UDI
- Basic UDI-DI
- 8430591ADAPTERRH 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
- Spain EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Endoscopic light source unit, line-powered
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
European Union Active
CE/MDR
United States Pending data
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 5247735e-170f-4bfd-8424-0509e2fd1218 61 fields · synced Jul 13, 2026
- FDA UDI 586a6085-5dcc-4186-9e75-9141fe614597 34 fields · synced May 30, 2026