Identity
- Trade Name
- ACEMST1.1 /RC EUDAMEDACEMST1 FDA UDI
- Generic Name
- Fixed examination/treatment room light FDA UDI
- Device Name
- LAMPADA SCIALITICA PER DIAGNOSTICA EUDAMEDACEMST1.1 ARTICULATED ARM CEILING FDA UDI
- Model / Reference
- ACEMST1 EUDAMED110805 EUDAMEDACEMST1.1 /RC FDA UDI
- Description
- ACEMST1.1 ARTICULATED ARM CEILING FDA UDI
Identifiers
- Catalog Number
- 110805 FDA UDI
- Primary DI / UDI-DI
- 08050705890095 EUDAMEDFDA UDI
- Basic UDI-DI
- 805070589ACEMST1EM EUDAMED
- Direct Marketing DI
- 08050705890095 EUDAMED
- FDA Product Code
- KZF FDA UDI
- EMDN Code
- Z12010701 FIXED SCIALYTIC LAMPS EUDAMED
- GMDN Term
- Fixed examination/treatment room light FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6320 FDA UDI
- Market of Registration
- Italy 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Fixed examination/treatment room light
Acemst1 by Acem Spa — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Acem Spa
Sources (2)
- FDA UDI d87c56bd-b046-464b-b8d0-2aa226041d91 34 fields · synced Jul 23, 2026
- EUDAMED 44b1cf15-ca87-4ab3-81a5-6f16a815f738 61 fields · synced Jul 23, 2026