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Orascoptic - RDH Elite Rx
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref Rx RDH 2.5x Standard Frame
Identity
- Trade Name
- Orascoptic - RDH Elite Rx FDA UDI
- Generic Name
- Surgical binoculars, reusable FDA UDI
- Device Name
- Loupe/Powered Loupe EUDAMEDNA FDA UDI
- Model / Reference
- Rx RDH 2.5x Standard Frame EUDAMEDRDH Elite Rx FDA UDI
- Description
- NA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00615375009970 EUDAMEDFDA UDI
- Basic UDI-DI
- 06153753000002EP EUDAMED
- FDA Product Code
- FSP FDA UDI
- EMDN Code
- Z129004 LIGHT SOURCES EUDAMED
- GMDN Term
- Surgical binoculars, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 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: Surgical binoculars, reusable
Orascoptic - RDH Elite Rx by Metrex Research — 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
- Enova Illumination — ENOVA ILLUMINATION, INC · 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
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
- Metrex Research
Sources (2)
- FDA UDI 29b8c1c1-f631-4557-9f33-9bcf758dba3f 35 fields · synced Jul 31, 2026
- EUDAMED 820b5b29-27b5-44c8-ac66-75d30930d456 61 fields · synced Jul 31, 2026