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NeoGlo® Disposable Transilluminator - Red Lights
EUDAMEDFDA UDIClass I (EU MDR)
Ref N5536RDModel NeoGlo® Disposable
Identity
- Trade Name
- NeoGlo® Disposable Transilluminator - Red Lights EUDAMEDNeoGlo® Disposable FDA UDI
- Generic Name
- Visible-light skin transilluminator FDA UDI
- Device Name
- NeoGlo® Disposable EUDAMEDThe NeoGlo Disposable Transilluminator is a hand-held, single patient use device that is a light source intended to transmit light through tissue to aid in examination of patients. FDA UDI
- Model / Reference
- NeoGlo® Disposable EUDAMEDN5536RD EUDAMEDRed FDA UDI
- Description
- The NeoGlo Disposable Transilluminator is a hand-held, single patient use device that is a light source intended to transmit light through tissue to aid in examination of patients. FDA UDI
Identifiers
- Catalog Number
- N5536RD FDA UDI
- Primary DI / UDI-DI
- 10812594013086 EUDAMEDFDA UDI
- Basic UDI-DI
- 081259401N55500MV EUDAMED
- FDA Product Code
- HJM FDA UDI
- EMDN Code
- W0202030202 TRANSILLUMINATORS EUDAMED
- GMDN Term
- Visible-light skin transilluminator FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1945 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
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
NeoGlo® Disposable Transilluminator - Red Lights by Neotech Products 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 | 081259401N55500MV | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Neotech Products LLC
- EUDAMED SRN
- US-MF-000001895
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 62cc01d8-02ea-4c04-87ea-6375d3f9cd95 61 fields · synced Aug 2, 2026
- FDA UDI e7ca74c9-a91c-44bc-80e8-b40c62345ac9 34 fields · synced May 30, 2026