Identity
- Trade Name
- AMT Balloon Measuring Device EUDAMED
- Device Name
- Balloon Stoma Measurement Device EUDAMED
- Model / Reference
- E1904 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00842071152956 EUDAMED
- Basic UDI-DI
- 08420711BMDQE EUDAMED
- EMDN Code
- V0380 DEVICES WITH MEASURING FUNCTIONS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
AMT Balloon Measuring Device by Applied Medical Technology, Inc. — 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 | 08420711BMDQE | Class IIa | Active |
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Manufacturer
- Manufacturer
- Applied Medical Technology, Inc.
- EUDAMED SRN
- US-MF-000041414
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED cadc48df-4637-4551-9ea0-70dc6dbf66ee 61 fields · synced Jul 9, 2026