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Dermlite
EUDAMEDFDA UDIClass I (EU MDR)
Ref DLMC-N1Ref DL1SRef GLBRef DL4
by DermLite LLC
Identity
- Trade Name
- DERMLITE EUDAMEDDL1 Polarized Spacer FDA UDI
- Generic Name
- Dermatoscope, optical FDA UDI
- Device Name
- MagnetiConnect® for Nikon 1 Series EUDAMEDDL1 Polarized Spacer EUDAMEDDermLite GL Battery EUDAMEDDermLite DL4 EUDAMEDMagnetiConnect for Nikon 1 AW1 EUDAMEDSlide-on polarized spacer for DL1 FDA UDI
- Model / Reference
- DLMC-N1 EUDAMEDDL1S EUDAMEDFDA UDIGLB EUDAMEDDL4 EUDAMED
- Description
- Slide-on polarized spacer for DL1 FDA UDI
Identifiers
- Catalog Number
- DL1S FDA UDI
- Primary DI / UDI-DI
- 08500176513950 EUDAMED08559970069996 EUDAMED08500176511048 EUDAMED08559970063024 EUDAMED08500176510676 EUDAMED00855997006999 FDA UDI
- Basic UDI-DI
- 0850017651395TE EUDAMED08559970069999D EUDAMED0850017651104S7 EUDAMED085599700630276 EUDAMED0850017651067SS EUDAMED
- FDA Product Code
- KYT FDA UDI
- EMDN Code
- Z12040108 DERMATOSCOPES EUDAMED
- GMDN Term
- Dermatoscope, optical FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6350 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
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dermlite by DermLite LLC — 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 | 0850017651395TE | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DermLite LLC
- EUDAMED SRN
- US-MF-000005170
- Authorised Representative
- E C REP LIMITED IE-AR-000003995
Sources (6)
- EUDAMED 3ae31819-ad86-4707-b6e9-6a48a5e98bb8 61 fields · synced Aug 1, 2026
- EUDAMED 396255f4-cad7-4b2d-9390-168d3280a577 61 fields · synced May 17, 2026
- EUDAMED ad791040-378e-4739-bec1-18bce3b63a31 61 fields · synced May 17, 2026
- EUDAMED 29774dde-f986-4a0c-873c-fd3cf146ff21 61 fields · synced May 18, 2026
- EUDAMED 9efb4d42-f838-4d6e-9be6-17b6f22f3e97 61 fields · synced May 19, 2026
- FDA UDI 1a3cea49-350f-4faa-bbfb-044f1ce260f8 35 fields · synced May 29, 2026