Identity
- Trade Name
- Henry Schein EUDAMED
- Device Name
- Sterilisation Packaging EUDAMED
- Model / Reference
- TF-335 (HS) EUDAMED9003058 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10304040110666 EUDAMED
- Basic UDI-DI
- 03040433501CG EUDAMED
- Unit of Use DI
- 00304040110669 EUDAMED
- EMDN Code
- S01010101 STERILISATION POUCHES, FLAT, PAPER/PLASTIC FILM 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 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 | 03040433501CG | 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 b2d83936-42d1-416a-b7aa-6bad58582e74 61 fields · synced May 23, 2026