Identity
- Trade Name
- HARTMAN SPECULA EUDAMED
- Device Name
- HARTMAN SPECULA EUDAMED
- Model / Reference
- 39-100 RI EUDAMED
Identifiers
- Primary DI / UDI-DI
- ++G26839100RIZ7 EUDAMED
- Basic UDI-DI
- B-++G26839100RIZ7 EUDAMED
- EMDN Code
- L149004 ENT SPECULUMS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Hartman Specula by Raydent Instruments — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-++G26839100RIZ7 | Class I | Active |
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Manufacturer
- Manufacturer
- Raydent Instruments
- EUDAMED SRN
- PK-MF-000032781
- Authorised Representative
- ANTEX MEDI SOLUTION DE-AR-000008078
Sources (1)
- EUDAMED 11c993c7-7666-4b44-b206-8ff187029568 61 fields · synced Jun 19, 2026