FDA Registration
Active
🇨🇦 Canada
Hygie Canada Inc.
Reg #: 3008221237
·
FEI: 3008221237
·
Expires 2026
Products
10
Proprietary Names
42
Establishment Types
3
Classifications
10
Registration Details
- Registration Name
- Hygie Canada Inc.
- Registration Number
- 3008221237
- FEI Number
- 3008221237
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 800 Rocheleau St, Bureau 204
- City
- Drummondville Quebec
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K201530
Owner / Operator
- Firm Name
- Hygie Canada Inc.
- Operator Number
- 10046551
- Address
- 1000 rue du Lux, Suite 210
- City
- Brossard
- State
- Quebec
- Postal Code
- J4Y 0E3
- Country
- CA
US Agent
- Business Name
- EMERGO GLOBAL REPRESENTATION LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Caves Rd Ste 1 Ste 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2023-09-19 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2023-09-19 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2023-09-19 |
| Scraper, Tongue | LCN | Class 1 | Dental | No | 2022-07-22 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2015-11-09 |
| Urinal | FNP | Class 1 | General Hospital | No | 2015-11-09 |
| Attachment, Commode, Wheelchair | INB | Class 1 | Physical Medicine | No | 2014-04-07 |
| Bedpan | FOB | Class 1 | General Hospital | No | 2014-04-07 |
| Basin, Emesis | FNY | Class 1 | General Hospital | No | 2014-04-07 |
| Scale, Sponge, Surgical, Electrically-Powered | MRL | Class 1 | General Hospital | No | 2015-11-09 |
Proprietary Names
GO GLOV Disposable Dry Glove
Hygienic Super Absorbent Powder
Hygie Super-Absorbent Pad
Hygie Extra-Absorbent Pad
Hygie Wet Wash Gloves
Hygienic Wet Wash Gloves
Urinal Kit
Urinal Bag
Hygie Hy21 Urinal Support
Uri ProHy21 Kit
GO PEE Refill
GO PEE Kit
Urinal Hygienic Cover
Hygie Classic Commode Chair
Hygie Alu-Classic Commode
Accessories Plate for Commode
Seats for Commode
Replacement Parts for Commode
Hy21 Seat for Hygie Commode Chair/Pail
Hy-SO Isolation Kit
Hygie Absorbent Pads
Hygie Hygienic Covers for Bedpan and Commode
Hy21 Bedpan Support
Toilet Hygienic Cover
Hy-So Kit
Hygienic Cover Dispenser
Pail/Orthopedic Bedpan Hygienic Cover
Bedpan Seat Hy21
Kit EBOLA
Bedpan Kit
Hygie Hy21 Bedpan Support Extender
Bedpan ProHy21 Kit
Bedpan/Commode Hygienic Cover
Splatter Proof Pail
Hygienic Garbage Bags
Vomit Kit
Vomit Hygienic Cover
Hygie Hy21 Vomit Support
GOVOM Vomit Bags
Vom ProHy21 Kit
Hanging Scale Cover
Hygie Cylindrical Hanging Scale
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device