Identity
- Trade Name
- Round bowl 40mm ml.30 EUDAMED
- Device Name
- Round bowl 40mm ml.30 EUDAMED
- Model / Reference
- 8961103944047 EUDAMEDBi17-343 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08961103944047 EUDAMED
- Basic UDI-DI
- 896110394Bi17-343LX EUDAMED
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Round bowl 40mm ml.30 by Battan International — 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 | 896110394Bi17-343LX | Class I | Active |
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Manufacturer
- Manufacturer
- Battan International
- EUDAMED SRN
- PK-MF-000043557
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (1)
- EUDAMED 85bf1367-5efc-4397-88b7-97189641c947 61 fields · synced Jul 21, 2026