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MolecuLightDX
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 1594Model MolecuLightDX
Identity
- Trade Name
- MolecuLightDX EUDAMEDMolecuLightDX DarkDrape FDA UDI
- Generic Name
- Patient surgical drape, single-use FDA UDI
- Device Name
- MolecuLightDX EUDAMEDDrapes individually packaged for one-time use to create an optimal lighting environment for imaging wounds using the MolecuLightDX. FDA UDI
- Model / Reference
- MolecuLightDX EUDAMED1594 EUDAMED1973 FDA UDI
- Description
- Drapes individually packaged for one-time use to create an optimal lighting environment for imaging wounds using the MolecuLightDX. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00628110259424 EUDAMED00628110259394 FDA UDI
- Basic UDI-DI
- 628110259TD0032A EUDAMED
- FDA Product Code
- PUI FDA UDI
- EMDN Code
- Z12019003 WOUND TREATMENT EQUIPMENT EUDAMED
- GMDN Term
- Patient surgical drape, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4370 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MolecuLightDX by MolecuLight Inc — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K211901 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 628110259TD0032A | Class IIa | Active |
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Manufacturer
- Manufacturer
- MolecuLight Inc.
- EUDAMED SRN
- CA-MF-000036119
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED ce065be2-23e8-4fdd-8a4c-403a69e91d31 61 fields · synced Jul 11, 2026
- FDA UDI 46999456-54d3-4d97-892e-0ec94030a5a1 33 fields · synced May 25, 2026
- FDA 510(k) K211901 1 fields · synced May 18, 2026