Identity
- Trade Name
- Impression tray perf. BO 3ss EUDAMED
- Device Name
- Impression tray perf. BO 3ss EUDAMED
- Model / Reference
- 8610103 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G47286101030 EUDAMED
- Basic UDI-DI
- ++G4728610103VC EUDAMED
- EMDN Code
- Q01020199 DENTAL IMPRESSION MATERIALS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Impression tray perf. BO 3ss by HB Meditech (Pvt) Limited — 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 | ++G4728610103VC | Class I | Active |
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Manufacturer
- Manufacturer
- HB Meditech (Pvt) Limited
- EUDAMED SRN
- PK-MF-000024590
- Authorised Representative
- ANTEX MEDI SOLUTION DE-AR-000008078
Sources (1)
- EUDAMED 452a87be-0156-4179-a264-864f4ed1b71e 61 fields · synced Sep 17, 2026