Identity
- Trade Name
- Reflux Wedge EUDAMED
- Device Name
- Positioning Device EUDAMED
- Model / Reference
- 10CDE-RW EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00815090013034 EUDAMED
- Basic UDI-DI
- 081509001POSITIONING5X EUDAMED
- Unit of Use DI
- 00815090014581 EUDAMED
- EMDN Code
- V0299 NEONATOLOGY AND PAEDIATRIC DEVICES - OTHER 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
Reflux Wedge by Small Beginnings, Inc. — 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 | 081509001POSITIONING5X | Class I | Active |
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Manufacturer
- Manufacturer
- Small Beginnings, Inc.
- EUDAMED SRN
- US-MF-000021428
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 131c1c63-b19a-4beb-a880-c01207e9b062 61 fields · synced Jun 18, 2026