Identity
- Trade Name
- Specula, Vaginal EUDAMED
- Model / Reference
- Specula, Vaginal EUDAMEDZA-002-788 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049203087520 EUDAMED
- Basic UDI-DI
- 40492030000024BB EUDAMED
- Direct Marketing DI
- 04049203087520 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
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
Category: Vaginal speculum, reusable
Specula, Vaginal by STEMA Medizintechnik GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 40492030000024BB | Class I | Active |
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Manufacturer
- Manufacturer
- STEMA Medizintechnik GmbH
- EUDAMED SRN
- DE-MF-000005523
Sources (1)
- EUDAMED 0539410d-a585-4d80-bb2c-4463a0af2620 61 fields · synced Jul 11, 2026