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Digital Refractor
EUDAMEDFDA UDIClass I (EU MDR)
Ref D1ARAA-16-00003Model HDR-7100P, HDR-7000P, HDR-9000, HDR-7000
Identity
- Trade Name
- Digital Refractor HDR-9000 FDA UDI
- Generic Name
- Phoropter FDA UDI
- Device Name
- Digital Refractor EUDAMEDDigital Refractor system is a computerized auto refractor used for subjective refraction by regarding the patient’s accommodation power and facilities. FDA UDI
- Model / Reference
- HDR-7100P, HDR-7000P, HDR-9000, HDR-7000 EUDAMEDD1ARAA-16-00003 EUDAMEDHDR-9000 FDA UDI
- Description
- Digital Refractor system is a computerized auto refractor used for subjective refraction by regarding the patient’s accommodation power and facilities. FDA UDI
Identifiers
- Catalog Number
- HDR-9000 FDA UDI
- Primary DI / UDI-DI
- 08800019600213 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000196DR001C8 EUDAMED
- Direct Marketing DI
- 08800019600213 EUDAMED
- FDA Product Code
- HKN FDA UDI
- EMDN Code
- Z12120115 OPTOMETERS EUDAMED
- GMDN Term
- Phoropter FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1770 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Digital Refractor by Huvitz Co., Ltd. — 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 | 88000196DR001C8 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Huvitz Co., Ltd.
- EUDAMED SRN
- KR-MF-000015802
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 73f624ce-bf09-4885-9970-79661804363f 61 fields · synced Jul 13, 2026
- FDA UDI 66348225-37c3-4ddb-99ad-7744baf17b46 35 fields · synced May 30, 2026