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Insert for collecting containers
EUDAMEDFDA UDIClass I (EU MDR)
Ref 2228.802Model 10000201412
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Surgical fluid/smoke waste management system suction unit FDA UDI
- Device Name
- Insert for collecting containers EUDAMEDTUBE INSERT for hysteroscopy, for the suction of tissue during resection FDA UDI
- Model / Reference
- 10000201412 EUDAMED2228.802 EUDAMED2228802 FDA UDI
- Description
- TUBE INSERT for hysteroscopy, for the suction of tissue during resection FDA UDI
Identifiers
- Catalog Number
- 2228.802 FDA UDI
- Primary DI / UDI-DI
- 04055207011928 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520727052019-0018609PS EUDAMED
- Direct Marketing DI
- 04055207011928 EUDAMED
- FDA Product Code
- FJL FDA UDI
- EMDN Code
- Z12029099 VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI–INVASIVE SURGERY – OTHER EUDAMED
- GMDN Term
- Surgical fluid/smoke waste management system suction unit FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Insert for collecting containers by Richard Wolf GmbH — 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 | 405520727052019-0018609PS | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Richard Wolf GmbH
- EUDAMED SRN
- DE-MF-000007048
Sources (2)
- EUDAMED 1ec12684-a287-404f-8913-e1bc0e0fabe0 61 fields · synced Jun 18, 2026
- FDA UDI 439942f9-2fa5-4e6f-91e4-6f35757bb397 35 fields · synced May 30, 2026