10 results
10-Q
2024 Q1
GUTS
Fractyl Health Inc.
13 May 24
Quarterly report
4:06pm
we intend to sell medical devices in member states of the European Union, or EU, our products must comply with the general safety and performance … . Business—Government Regulations—Regulation of Medical Devices in the European Union for more information.
The CE mark for Revita was issued under the MDD
10-K
2023 FY
GUTS
Fractyl Health Inc.
1 Apr 24
Annual report
7:15am
is for Investigational use only in the United States. Revita has a CE mark in the European Union. Prototype Rendering
Procedure Overview
The Revita DMR … ADAs and 20 to 100 units of insulin daily. The study is to take place across approximately 35 sites in the United States and the European Union
424B4
GUTS
Fractyl Health Inc.
2 Feb 24
Prospectus supplement with pricing info
4:18pm
of the European Union, or EU, our products must comply with the general safety and performance requirements of the Medical Devices Regulation, or MDR … products, which would prevent us from selling them within the EU. See “Government Regulations—Regulation of Medical Devices in the European Union
S-1/A
GUTS
Fractyl Health Inc.
29 Jan 24
IPO registration (amended)
6:09am
apply in foreign jurisdictions.
To the extent we intend to sell medical devices in member states of the European Union, or EU, our products must … them within the EU. See “Government Regulations—Regulation of Medical Devices in the European Union” for more information.
The CE mark for Revita
S-1/A
EX-1.1
GUTS
Fractyl Health Inc.
29 Jan 24
IPO registration (amended)
6:09am
Nations Security Council, the European Union, His Majesty’s Treasury, or other relevant sanctions authority (collectively, “Sanctions”), nor is the Company
S-1
coa caji7vu4p483
14 Dec 23
IPO registration
3:39pm
S-1
EX-10.1
xjfej1 f4471q
14 Dec 23
IPO registration
3:39pm
S-1
EX-10.10
p3tfitr9vn
14 Dec 23
IPO registration
3:39pm
DRS/A
splk31s cc5mhv
21 Sep 23
Draft registration statement (amended)
12:00am
DRS/A
c4wj0
22 Aug 23
Draft registration statement (amended)
12:00am
- Prev
- 1
- Next