Identity
- Model / Reference
- Eye Speculum EUDAMEDH-1058A-1.0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250326814287 EUDAMED
- Basic UDI-DI
- 4250326800010018X4 EUDAMED
- Direct Marketing DI
- 04250326814287 EUDAMED
- EMDN Code
- L170102 OCULAR AND ENDOCULAR RETRACTORS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
H-1058a-1.0 by Albert Heiss GmbH & Co. KG — 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 | 4250326800010018X4 | Class I | Active |
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Manufacturer
- Manufacturer
- Albert Heiss GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000005495
Sources (1)
- EUDAMED 96dc3f7f-db97-4fc2-af24-c2dd6981fb6b 61 fields · synced Sep 30, 2026