Identity
- Trade Name
- NA FDA UDI
- Generic Name
- General-purpose syringe, reusable FDA UDI
- Device Name
- Adapters EUDAMEDADAPTER for Toomey syringes, with cone, reusable FDA UDI
- Model / Reference
- 10000201164 EUDAMED845.11 EUDAMED84511 FDA UDI
- Description
- ADAPTER for Toomey syringes, with cone, reusable FDA UDI
Identifiers
- Catalog Number
- 845.11 FDA UDI
- Primary DI / UDI-DI
- 04055207008294 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520727052019-0017818PW EUDAMED
- Direct Marketing DI
- 04055207008294 EUDAMED
- FDA Product Code
- KYZ FDA UDI
- EMDN Code
- L060413 ENDOSCOPIC UROLOGY ADAPTERS AND CONNECTORS, REUSABLE EUDAMED
- GMDN Term
- General-purpose syringe, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6960 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
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
Adapters 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 | 405520727052019-0017818PW | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Richard Wolf GmbH
- EUDAMED SRN
- DE-MF-000007048
Sources (2)
- EUDAMED d1e0a94e-67f1-4ab9-a1c7-5fad6cd8e8b3 61 fields · synced Jul 18, 2026
- FDA UDI 724eea68-c275-4bce-838b-5f61c559154d 35 fields · synced May 29, 2026