Identity
- Trade Name
- Bgood EUDAMED
- Device Name
- Surgical Mask EUDAMED
- Model / Reference
- BCM10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08681285112446 EUDAMED
- Basic UDI-DI
- 868128511BCM10019Q EUDAMED
- EMDN Code
- T020603 MEDICAL USE FACE MASKS, TYPE I (NOT FOR HEALTHCARE PROFESSIONALS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Bgood by Honnes Sağlık ve Endüstriyel Ürünleri A.Ş — 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 | 868128511BCM10019Q | Class I | Active |
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Manufacturer
- Manufacturer
- Honnes Sağlık ve Endüstriyel Ürünleri A.Ş
- EUDAMED SRN
- TR-MF-000017199
Sources (1)
- EUDAMED 76ea8985-f3aa-4152-a53b-7df5cba1be36 61 fields · synced Oct 5, 2026