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Rectal Syringe
EUDAMEDFDA UDIClass I (EU MDR)
Ref 89mlModel 8ml, 25ml, 27ml, 40ml, 52ml, 65ml, 85ml, 89ml, 90ml, 95ml, 102ml, 115ml, 120ml, 143ml, 160ml, 165ml, 200ml, 205ml, 210ml, 216ml, 220ml, 224ml, 225ml, 275ml, 320ml, 347ml, 350ml, 355ml, 365ml, 420ml, 450ml, 483ml, 1oz,2oz, 3oz, 4oz, 5oz, 6oz, 7oz, 8oz
Identity
- Trade Name
- None FDA UDI
- Generic Name
- Manual enema device, reusable FDA UDI
- Device Name
- Rectal Syringe EUDAMED
- Model / Reference
- 8ml, 25ml, 27ml, 40ml, 52ml, 65ml, 85ml, 89ml, 90ml, 95ml, 102ml, 115ml, 120ml, 143ml, 160ml, 165ml, 200ml, 205ml, 210ml, 216ml, 220ml, 224ml, 225ml, 275ml, 320ml, 347ml, 350ml, 355ml, 365ml, 420ml, 450ml, 483ml, 1oz,2oz, 3oz, 4oz, 5oz, 6oz, 7oz, 8oz EUDAMED89ml EUDAMED1.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971919469063 EUDAMEDFDA UDI
- Basic UDI-DI
- 697191946RS68 EUDAMED
- FDA Product Code
- KYZ FDA UDI
- EMDN Code
- A020299 REUSABLE SYRINGES - OTHER EUDAMED
- GMDN Term
- Manual enema device, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6960 FDA UDI
- Market of Registration
- Belgium 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
Rectal Syringe 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 | 697191946RS68 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ningbo Albert Novosino Co., Ltd.
- EUDAMED SRN
- CN-MF-000008571
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (2)
- EUDAMED 7c9a79e5-a26c-4805-ad49-04ab8e594c66 61 fields · synced Jun 17, 2026
- FDA UDI 15af7d89-7b94-4f1f-bd47-46de0f841c50 32 fields · synced May 30, 2026