Identity
- Trade Name
- Ophthalmic Specula EUDAMED
- Device Name
- Ophthalmic Specula EUDAMED
- Model / Reference
- E1-1020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G644E110201 EUDAMED
- Basic UDI-DI
- ++G644OphthalmicSpeculuYA EUDAMED
- EMDN Code
- L170102 OCULAR AND ENDOCULAR RETRACTORS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
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
Ophthalmic Specula by Satellite Industries — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++G644OphthalmicSpeculuYA | Class I | Active |
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Manufacturer
- Manufacturer
- Satellite Industries
- EUDAMED SRN
- PK-MF-000041675
- Authorised Representative
- International Business Compendious of Sweden SE-AR-000001625
Sources (1)
- EUDAMED 776c64bb-78dd-4f17-a054-134644f4b9a4 61 fields · synced Jun 19, 2026