Identity
- Trade Name
- Hygostar EUDAMED
- Device Name
- Blue Cohesive Tape EUDAMED
- Model / Reference
- 01-1801 / 01-1802 EUDAMEDFM-50028 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04015544715118 EUDAMED
- Basic UDI-DI
- 48079990API093NG EUDAMED
- EMDN Code
- M030402020103 ELASTIC SUPPORT BANDAGES, COHESIVE, EXTENSIBLE IN TWO DIRECTIONS, HIGH EXTENSIBILITY 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
Hygostar 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 | 48079990API093NG | 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 ad5cca89-e188-44c1-b542-05be31df2e3b 61 fields · synced Jul 14, 2026