Identity
- Trade Name
- SURVAC™ FDA UDI
- Generic Name
- Suction system catheter, general-purpose FDA UDI
- Device Name
- SURVAC™ EUDAMEDSuction Catheters for Bronchoscopy PC, 3 x 4, L 60 FDA UDI
- Model / Reference
- 77642 EUDAMEDFDA UDI
- Description
- Suction Catheters for Bronchoscopy PC, 3 x 4, L 60 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 14063108108668 EUDAMEDFDA UDI
- Basic UDI-DI
- 4063108SURCB EUDAMED
- FDA Product Code
- BSY FDA UDI
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
- GMDN Term
- Suction system catheter, general-purpose FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.6810 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Category: Pulmonary function analysis system, adult
Survac™ by Novatech Sa — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 4063108SURCB | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Novatech Sa
- EUDAMED SRN
- FR-MF-000001658
Sources (2)
- EUDAMED 1dd3ac02-5166-49af-92fa-c63a403de651 61 fields · synced Sep 18, 2026
- FDA UDI fea7a304-f1a0-4bb6-a740-bb8c1d4007d2 33 fields · synced May 30, 2026