Identity
- Trade Name
- Enova Illumination EUDAMEDFDA UDI
- Generic Name
- Surgical binoculars, reusable FDA UDIHead-worn lamp FDA UDIElectrical-only medical device connection cable, reusable FDA UDI
- Device Name
- LED Surgical Headlight with Battery Accessories EUDAMEDMicro Ergo Angled Prismatic 3.5x Oculars FDA UDIQuasar Cool/XLT-150A LED Surgical Light FDA UDIGrey Twist Battery Cable FDA UDI
- Model / Reference
- 80088 EUDAMEDFDA UDI80302-001 EUDAMEDFDA UDI820012-001 FDA UDI
- Description
- Micro Ergo Angled Prismatic 3.5x Oculars FDA UDIQuasar Cool/XLT-150A LED Surgical Light FDA UDIGrey Twist Battery Cable FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850025993487 EUDAMEDFDA UDI00850025993692 EUDAMEDFDA UDI00810186670115 FDA UDI
- Basic UDI-DI
- 0850025993EnovaHLSysGQ EUDAMED
- FDA Product Code
- FSP FDA UDIHPP FDA UDI
- EMDN Code
- V80 CLINICAL USE ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMEDZ129004 LIGHT SOURCES EUDAMED
- GMDN Term
- Surgical binoculars, reusable FDA UDIHead-worn lamp FDA UDIElectrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI886.4335 FDA UDI
- Market of Registration
- Austria EUDAMEDMalta 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical binoculars, reusable
Enova Illumination by Enova Illumination, Inc — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical binoculars, reusable.
- Brilliance — CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD. · Class I
- SurgiTel — Surgitel · Class I
- Surgical Telescope — Xenosys Co., Ltd. · Class I
- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- SuperVu XL Advantage 3.5x, at 34cm working distanc — Rudolf Riester GmbH & Co. KG · Class I
- Surgical Telescope — Xenosys Co., Ltd. · Class I
- PENTAX PRISMVUE NF2 L25S(S) — HOYA Technosurgical Corporation · Class I
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
- Enova Illumination, Inc
Sources (5)
- FDA UDI 87aaf28e-dfda-4911-b8a2-b8ee7a2a6fda 33 fields · synced Sep 30, 2026
- FDA UDI 4bcd38b7-c193-450b-accd-240a1a154c2a 33 fields · synced May 30, 2026
- FDA UDI b5f0a64b-b732-4ac9-bf5a-0437c798b1a2 33 fields · synced May 30, 2026
- EUDAMED 274e6595-0291-4959-96d8-0584e7d33939 61 fields · synced Jul 8, 2026
- EUDAMED 95835456-8232-414a-81de-01e151b6b9e3 61 fields · synced Aug 2, 2026