Identity
- Trade Name
- Vaginal Applicator EUDAMED
- Device Name
- Vaginal Applicator EUDAMED
- Model / Reference
- 70001128 EUDAMED20005321 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04032651962761 EUDAMED04032651987504 EUDAMED
- Basic UDI-DI
- 4032651-BSC00000009-DA EUDAMED
- EMDN Code
- U089009 VAGINAL APPLICATORS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMEDGermany 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Vaginal Applicator by Schülke & Mayr GmbH — 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 | 4032651-BSC00000009-DA | Class I | Active |
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Manufacturer
- Manufacturer
- Schülke & Mayr GmbH
- EUDAMED SRN
- DE-MF-000005701
Sources (2)
- EUDAMED ad5ca937-eff8-41e2-9b11-6e45e0abd3ef 61 fields · synced Jul 29, 2026
- EUDAMED b0678a91-39c2-4156-ab6d-b92d8b452320 61 fields · synced May 17, 2026