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Amara Balloon Dilator
EUDAMEDClass IIa (EU MDR)
Ref GDB-0120655SModel Amara Balloon DilatorRef GDB-0110655SRef GDB-0221255SRef GDB-0211255SRef GDB-0210655SRef GDB-0120855SRef GDB-0221555SRef GDB-0211555SRef GDB-0220655SRef GDB-0110855SRef GDB-0111255S
by Envaste Ltd
Identity
- Trade Name
- Amara Balloon Dilator EUDAMED
- Device Name
- Amara Balloon Dilator EUDAMED
- Model / Reference
- Amara Balloon Dilator EUDAMEDGDB-0120655S EUDAMEDGDB-0110655S EUDAMEDGDB-0221255S EUDAMEDGDB-0211255S EUDAMEDGDB-0210655S EUDAMEDGDB-0120855S EUDAMEDGDB-0221555S EUDAMEDGDB-0211555S EUDAMEDGDB-0220655S EUDAMEDGDB-0110855S EUDAMEDGDB-0111255S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 60913190400722 EUDAMED60913190400104 EUDAMED60913190402252 EUDAMED60913190401644 EUDAMED60913190401330 EUDAMED60913190400890 EUDAMED60913190402320 EUDAMED60913190401712 EUDAMED60913190401958 EUDAMED60913190400272 EUDAMED60913190400418 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 EUDAMEDTürkiye 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 (11)
- EUDAMED c000b216-7fc9-45b4-93b2-74a0e43adf8e 61 fields · synced Aug 2, 2026
- EUDAMED 1934c04a-2ffc-4a83-845e-f1ff7d2f5677 61 fields · synced May 11, 2026
- EUDAMED 458ca45d-3fe1-48b4-bac7-c204fe5829ab 61 fields · synced May 16, 2026
- EUDAMED afd4f853-7255-4d9c-be8e-ccd06a1f92e9 61 fields · synced May 17, 2026
- EUDAMED ef21c61e-c737-452b-8139-02240165e603 61 fields · synced May 17, 2026
- EUDAMED 59050df3-9cc9-4237-a8df-42e6a1cd66d5 61 fields · synced May 17, 2026
- EUDAMED 67ed84b2-2840-449f-b3db-72185b3d0797 61 fields · synced May 18, 2026
- EUDAMED 2427f3f8-d7e8-45d8-8110-82a4843923ba 61 fields · synced May 18, 2026
- EUDAMED f88477df-f4e6-4b10-a609-128b9d0d0ad1 61 fields · synced May 18, 2026
- EUDAMED 2172d821-6a89-4f06-98c4-9f512ed7a1f5 61 fields · synced May 19, 2026
- EUDAMED da594c27-9649-41d5-82e6-75906570eed4 61 fields · synced May 19, 2026