Identity
- Trade Name
- PRIMELINE EUDAMEDAESCULAP FDA UDI
- Generic Name
- Sterilization container filter, reusable FDA UDI
- Device Name
- PRIMELINE PRO filter EUDAMEDPRIMELINE Accessories Container, filter insert, PTFE FDA UDI
- Model / Reference
- JP050 EUDAMEDFDA UDI
- Description
- PRIMELINE Accessories Container, filter insert, PTFE FDA UDI
Identifiers
- Catalog Number
- JP050 FDA UDI
- Primary DI / UDI-DI
- 04038653354856 EUDAMEDFDA UDI
- Basic UDI-DI
- 4039239000001136ZV EUDAMED
- FDA Product Code
- KCT FDA UDI
- EMDN Code
- S010402 FILTERS FOR STERILISATION CONTAINERS EUDAMED
- GMDN Term
- Sterilization container filter, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6850 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Primeline by Aesculap AG — 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 | 4039239000001136ZV | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Aesculap AG
- EUDAMED SRN
- DE-MF-000005504
Sources (2)
- EUDAMED 7dd895ab-e578-4d1f-8ac5-2eac5767f4ab 61 fields · synced Jul 18, 2026
- FDA UDI 4c8e5751-83cf-4edb-9a75-2519c00358e9 35 fields · synced May 29, 2026