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Babel safe
EUDAMEDClass I (EU MDR)
Ref BAB-10005Model 39-0399 / 39-0400 / 39-0401 / 39-0500 / 39-0553 / 39-0556 / 39-1401/ 39-1553 / 39-1556
Identity
- Trade Name
- Babel safe EUDAMED
- Device Name
- Decorated plasters EUDAMED
- Model / Reference
- 39-0399 / 39-0400 / 39-0401 / 39-0500 / 39-0553 / 39-0556 / 39-1401/ 39-1553 / 39-1556 EUDAMEDBAB-10005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05901448250949 EUDAMED
- Basic UDI-DI
- 48079990API061N3 EUDAMED
- EMDN Code
- M0599 MEDICAL PLASTERS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Babel safe by Aso Philippines, 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 | 48079990API061N3 | Class I | Active |
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Manufacturer
- Manufacturer
- Aso Philippines, Inc.
- EUDAMED SRN
- PH-MF-000027714
- Authorised Representative
- Aso Europe BV NL-AR-000004377
Sources (1)
- EUDAMED e9170807-2fd8-461b-a882-442255f9e8db 61 fields · synced Jul 10, 2026