← Back to catalogue
Vaginal Douche
EUDAMEDFDA UDIClass I (EU MDR)
Ref 294mlModel 220ml, 275ml, 294ml, 310ml, 330ml, 347ml, 483ml
Identity
- Trade Name
- None FDA UDI
- Generic Name
- Vaginal douche, reusable FDA UDI
- Device Name
- Vaginal Douche EUDAMED
- Model / Reference
- 220ml, 275ml, 294ml, 310ml, 330ml, 347ml, 483ml EUDAMED294ml EUDAMED1.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971919469032 EUDAMEDFDA UDI
- Basic UDI-DI
- 697191946VD5N EUDAMED
- FDA Product Code
- HED FDA UDI
- EMDN Code
- A03040203 PERINEAL IRRIGATION KITS, SINGLE-USE EUDAMED
- GMDN Term
- Vaginal douche, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 884.5900 FDA UDI
- Market of Registration
- Austria 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Vaginal Douche by Ningbo Albert Novosino Co., Ltd. — 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 | 697191946VD5N | 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
- Ningbo Albert Novosino Co., Ltd.
- EUDAMED SRN
- CN-MF-000008571
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (2)
- EUDAMED 7dabb714-5a1d-4724-b146-32c60a89d5e2 61 fields · synced Jul 11, 2026
- FDA UDI 0b965e34-6aba-400d-84f9-1f5a3603e68b 32 fields · synced May 30, 2026