Identity
- Trade Name
- Aveta Roll Stand with Drape Pump EUDAMEDFDA UDI
- Generic Name
- Basic roller pump FDA UDI
- Device Name
- Aveta Roll Stand with Drape Pump EUDAMEDFDA UDI
- Model / Reference
- 212-205 EUDAMEDFDA UDI
- Description
- Aveta Roll Stand with Drape Pump FDA UDI
Identifiers
- Catalog Number
- 212-205 FDA UDI
- Primary DI / UDI-DI
- 00850006759033 EUDAMEDFDA UDI
- Basic UDI-DI
- 00850006759033CU EUDAMED
- Direct Marketing DI
- 00850006759033 EUDAMED
- 510(k) Number
- K190372 FDA UDI
- FDA Product Code
- HIG FDA UDIHIH FDA UDI
- EMDN Code
- Z12080203 HYSTEROSUCTION SURGICAL ASPIRATORS EUDAMED
- GMDN Term
- Basic roller pump FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.1700 FDA UDI884.1690 FDA UDI
- Market of Registration
- Denmark 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Aveta Roll Stand with Drape Pump by Meditrina, Inc. — 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 | 00850006759033CU | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Meditrina, Inc.
- EUDAMED SRN
- US-MF-000033191
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 0502428b-8f9c-42ca-8776-2349ac1d0bc1 61 fields · synced Jun 17, 2026
- FDA UDI a38e7b29-8da1-46d7-922f-024c129e144d 35 fields · synced May 30, 2026