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Amara Balloon Dilator
EUDAMEDClass IIa (EU MDR)
Ref GDB-0211055SModel Amara Balloon Dilator
by Envaste Ltd
Identity
- Trade Name
- Amara Balloon Dilator EUDAMED
- Device Name
- Amara Balloon Dilator EUDAMED
- Model / Reference
- Amara Balloon Dilator EUDAMEDGDB-0211055S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 60913190401576 EUDAMED
- Basic UDI-DI
- 60913190GDBTG EUDAMED
- EMDN Code
- G03010199 GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
Yes
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
Amara Balloon Dilator by Envaste Ltd — Class IIa — 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 | 60913190GDBTG | Class IIa | Active |
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Manufacturer
- Manufacturer
- Envaste Ltd
- EUDAMED SRN
- MU-MF-000030801
- Authorised Representative
- ENVASTE LTD IE-AR-000028866
Sources (1)
- EUDAMED 761f5589-4824-4e98-afd3-8373a4c72829 61 fields · synced Jun 18, 2026