Identity
- Trade Name
- Henry Schein Maxima EUDAMED
- Device Name
- Cotton Rolls and Pellets EUDAMED
- Model / Reference
- TF-109 (HS) EUDAMED9008526 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00304040099124 EUDAMED
- Basic UDI-DI
- 03040410901BR EUDAMED
- EMDN Code
- Q019004 DENTAL COTTON ROLLS 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
Henry Schein Maxima by Henry Schein, 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 | 03040410901BR | Class I | Active |
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Manufacturer
- Manufacturer
- Henry Schein Inc.
- EUDAMED SRN
- US-MF-000021683
- Authorised Representative
- Henry Schein Services GmbH DE-AR-000008001
Sources (1)
- EUDAMED c88d41c2-77ff-4c1c-9cad-9db992e356bf 61 fields · synced May 22, 2026