Identity
- Trade Name
- ADDplus EUDAMEDFDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- Layer for osmium instruments for osmium screw Ø 4.0 mm FDA UDI
- Model / Reference
- Layer EUDAMEDCS 1340-7 EUDAMEDFDA UDI
- Description
- Layer for osmium instruments for osmium screw Ø 4.0 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04052536219636 EUDAMEDFDA UDI
- Basic UDI-DI
- 4052536000340Q7 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 — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4052536000340Q7 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ulrich GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000006411
Sources (2)
- EUDAMED e7de4f3b-9a70-4b56-9975-3cb9706f1de0 61 fields · synced Jun 9, 2026
- FDA UDI c76d29d5-2246-4fe1-89ee-6eb68faa93da 34 fields · synced May 30, 2026