Identity
- Trade Name
- KRISTELLER VAGINAL SPECULA ( LARGE) EUDAMED
- Device Name
- KRISTELLER VAGINAL SPECULA ( LARGE) EUDAMED
- Model / Reference
- 61-154 RI EUDAMED
Identifiers
- Primary DI / UDI-DI
- ++G26861154RIZ9 EUDAMED
- Basic UDI-DI
- B-++G26861154RIZ9 EUDAMED
- EMDN Code
- L059001 VAGINAL 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
Category: Vaginal speculum, reusable
Kristeller Vaginal Specula ( Large) by Raydent Instruments — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-++G26861154RIZ9 | 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 9dc4c49b-24fb-4cfa-a0a6-09690f914b16 61 fields · synced Jun 18, 2026