Syn Tube 4 M 30 Suction Instrument
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- SYN TUBE 4 M 30 SUCTION INSTRUMENT EUDAMEDTrackable Suction - Tube 4-M-30 FDA UDI
- Generic Name
- Suction cannula, reusable FDA UDI
- Device Name
- Trackable Suction - Suction Set Standard EUDAMED
- Model / Reference
- SYN-0657 EUDAMEDSYN-0675 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00670082000313 EUDAMEDFDA UDI
- Basic UDI-DI
- 67008200003LM EUDAMED
- Direct Marketing DI
- 00670082000313 EUDAMED
- FDA Product Code
- GCX FDA UDI
- EMDN Code
- L030101 SUCTION AND IRRIGATION SURGICAL CANNULAS AND HANDPIECES, REUSABLE EUDAMED
- GMDN Term
- Suction cannula, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6740 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
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
No
Manufacturing Date
Yes
Category: Surgical/emergency suction cannula, non-illuminating, reusable
Syn Tube 4 M 30 Suction Instrument by Synaptive Medical Inc — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical/emergency suction cannula, non-illuminating, reusable.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 67008200003LM | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Synaptive Medical Inc.
- EUDAMED SRN
- CA-MF-000010705
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 1dad8b1a-53c3-4411-bf29-dc7b7912a620 61 fields · synced Jul 17, 2026
- FDA UDI 13719b79-9a72-4192-a0fe-9233b6e2a200 32 fields · synced May 27, 2026