Identity
- Device Name
- Packaged Prophylactic Oral Dam EUDAMED
- Model / Reference
- ps610-302 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09556807400723 EUDAMED
- Basic UDI-DI
- 9556807OD001YK EUDAMED
- Direct Marketing DI
- 09556807400723 EUDAMED
- EMDN Code
- Q019002 DENTISTRY DAMS AND HOOKS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Packaged Prophylactic Oral Dam by Richter Rubber Technology Sdn. Bhd. — Class IIb — 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 | 9556807OD001YK | Class IIb | Active |
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Manufacturer
- Manufacturer
- Richter Rubber Technology Sdn Bhd
- EUDAMED SRN
- MY-MF-000023324
- Authorised Representative
- rrt Vertrieb und Service GmbH DE-AR-000021443
Sources (1)
- EUDAMED 76b27387-0027-42e5-96ff-22438c7592bc 61 fields · synced Jun 18, 2026