Exsudex disposable canister
FDA UDIEUDAMEDClass I (US FDA UDI)
by Meditop B.V.
Identity
- Trade Name
- Exsudex XS Canister EUDAMEDExsudex disposable canister FDA UDI
- Generic Name
- Surgical suction system collection container, single-use FDA UDI
- Device Name
- Canister EUDAMEDThe Exsudex® Disposable Canister has the following features and is only to be used together with the Exsudex XS wound drainage system: - Canister capacity 300 cc; - Bacterial filter; - Fixed non-sterile suction tube with clamb and luer-lock connector - Dissolving sachet solidifying agent FDA UDI
- Model / Reference
- 16690-LL EUDAMEDCanister 300 ml with tube luer-lock FDA UDI
- Description
- The Exsudex® Disposable Canister has the following features and is only to be used together with the Exsudex XS wound drainage system: - Canister capacity 300 cc; - Bacterial filter; - Fixed non-sterile suction tube with clamb and luer-lock connector - Dissolving sachet solidifying agent FDA UDI
Identifiers
- Catalog Number
- 16690-LL FDA UDI
- Primary DI / UDI-DI
- 08718104890152 EUDAMEDFDA UDI
- Basic UDI-DI
- 871810489_CAN_NP EUDAMED
- FDA Product Code
- GCY FDA UDI
- EMDN Code
- A0680 DRAINAGE AND FLUID COLLECTION DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Surgical suction system collection container, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4680 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Surgical suction system collection container, single-use
Exsudex disposable canister by Meditop B.V. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Meditop B.V.
Sources (2)
- FDA UDI 8516b263-fc97-403f-99c4-e9ed8342da30 36 fields · synced Jul 12, 2026
- EUDAMED cb0d0b13-4258-46d9-8fb3-8ff3fb1ab755 61 fields · synced Jul 12, 2026