Identity
- Trade Name
- Amnicot EUDAMEDFDA UDI
- Generic Name
- Amniotic membrane perforator, single-use FDA UDI
- Device Name
- Amnicot EUDAMED
- Model / Reference
- ACD01-P EUDAMEDAmnicot German FDA UDI
Identifiers
- Catalog Number
- ACD01-G FDA UDI
- Primary DI / UDI-DI
- 09350902001966 EUDAMED09350902000211 FDA UDI
- Basic UDI-DI
- B-09350902001966 EUDAMED
- 510(k) Number
- K850758 FDA UDI
- FDA Product Code
- HGE FDA UDI
- EMDN Code
- U1005 AMNIOTIC MEMBRANE PERFORATORS EUDAMED
- GMDN Term
- Amniotic membrane perforator, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Market of Registration
- Poland 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
Yes
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Amniotic membrane perforator, single-use
Amnicot by Go Medical Industries Pty. Ltd. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Amniotic membrane perforator, single-use.
- Centurion — Centurion Medical Products · Class I
- ObstiHook — COOK INCORPORATED · Class I
- Amnihook Amniotic Membrane Perforator — Aspen Surgical Products, Inc. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- BUSSE HOSPITAL DISPOSABLES — ROBERT BUSSE & CO., INC. · Class I
- Amnicot — GO MEDICAL INDUSTRIES PTY. LTD. · Class I
Cleared under the same submission
K850758 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Go Medical Industries Pty. Ltd.
Sources (2)
- FDA UDI ca8966d2-86f8-4b86-ac6e-e9d71d6ea208 34 fields · synced Jul 27, 2026
- EUDAMED 3c63ac07-61b3-4fee-a79e-e7379ce3f95f 61 fields · synced Jul 27, 2026