Identity
- Trade Name
- NA FDA UDI
- Generic Name
- General-purpose syringe, reusable FDA UDI
- Device Name
- Bladder syringes EUDAMEDBLADDER SYRINGE 150 ML Ø 54MM Length 248mm, reusable FDA UDI
- Model / Reference
- 10000201184 EUDAMED822.31 EUDAMED82231 FDA UDI
- Description
- BLADDER SYRINGE 150 ML Ø 54MM Length 248mm, reusable FDA UDI
Identifiers
- Catalog Number
- 822.31 FDA UDI
- Primary DI / UDI-DI
- 04055207008034 EUDAMEDFDA UDI
- Basic UDI-DI
- 405520723052019-0017862J5 EUDAMED
- Direct Marketing DI
- 04055207008034 EUDAMED
- FDA Product Code
- KYZ FDA UDI
- EMDN Code
- U090204 BLADDER EVACUATORS 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
Dimensions & Sizes
- Size
- Outer Diameter — 54 Millimeter FDA UDI
Bladder syringes 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 | 405520723052019-0017862J5 | 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 3b0340c4-5f76-4f9f-b639-d0e52d96ddf7 61 fields · synced Jul 9, 2026
- FDA UDI f4b5251e-a9ca-4f9d-8432-e04871eea43f 36 fields · synced May 30, 2026