Identity
- Trade Name
- ADDplus EUDAMEDFDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- Complementary tray for osmium screw 4.0 mm FDA UDI
- Model / Reference
- Tray EUDAMEDCS 1340-8 EUDAMEDFDA UDI
- Description
- Complementary tray for osmium screw 4.0 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04052536219643 EUDAMEDFDA UDI
- Basic UDI-DI
- 4052536000359QU EUDAMED
- FDA Product Code
- LRP FDA UDI
- EMDN Code
- V0402 CLINICAL USE TRAYS AND BOWLS EUDAMED
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
ADDplus by ulrich GmbH & Co. KG — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K090841 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 4052536000359QU | Class I | Active |
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Manufacturer
- Manufacturer
- ulrich GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000006411
Sources (3)
- EUDAMED cd3a2506-c5be-41b4-956e-1dfac9c8fc53 61 fields · synced Oct 6, 2026
- FDA UDI 7afa824c-aae8-4711-918e-9c3e57514948 34 fields · synced May 30, 2026
- FDA 510(k) K090841 1 fields · synced May 18, 2026