Identity
- Trade Name
- Spiegel-Exophthalmometer nach Hertel EUDAMEDMirror Exophthalmometer acc. to Hertel FDA UDI
- Generic Name
- Exophthalmometer FDA UDI
- Device Name
- Spiegel-Exophthalmometer EUDAMEDMirror Exophthalmometer acc. to Hertel FDA UDI
- Model / Reference
- 52400 EUDAMEDFDA UDI
- Description
- Mirror Exophthalmometer acc. to Hertel FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049584007582 EUDAMEDFDA UDI
- Basic UDI-DI
- 404958420PP EUDAMED
- FDA Product Code
- HLS FDA UDI
- EMDN Code
- Z12120104 EXOPHTHALMOMETERS EUDAMED
- GMDN Term
- Exophthalmometer FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1270 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
Spiegel-Exophthalmometer nach Hertel by OCULUS Optikgeräte GmbH — 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 | 404958420PP | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- OCULUS Optikgeräte GmbH
- EUDAMED SRN
- DE-MF-000012227
Sources (2)
- EUDAMED cd0c4c79-2de1-404f-be78-10e2c071fd3c 61 fields · synced Jul 15, 2026
- FDA UDI c9918fc2-e71d-4409-beed-9610c2b4246e 34 fields · synced May 30, 2026