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Instylla Delivery Kit
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref INS90-3001-009Ref INS90-3001-010
Identity
- Trade Name
- Instylla Delivery Kit EUDAMEDFDA UDI
- Generic Name
- General-purpose syringe, single-use FDA UDI
- Device Name
- Instylla Delivery Kit EUDAMEDN/A FDA UDI
- Model / Reference
- INS90-3001-009 EUDAMEDINS90-3001-010 EUDAMEDINS90-3001-002 FDA UDI
- Description
- N/A FDA UDI
Identifiers
- Catalog Number
- N/A FDA UDI
- Primary DI / UDI-DI
- 00812013030321 EUDAMED00812013030338 EUDAMED00812013030000 FDA UDI
- Basic UDI-DI
- 081201303DK24D EUDAMED
- 510(k) Number
- K191659 FDA UDI
- FDA Product Code
- FMF FDA UDI
- EMDN Code
- A020102020102 INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE EUDAMED
- GMDN Term
- General-purpose syringe, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5860 FDA UDI
- 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
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
Instylla Delivery Kit by Instylla, Inc. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K202544 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K191659 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K213632 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K253769 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 081201303DK24D | Class I | Active |
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Manufacturer
- Manufacturer
- Instylla, Inc.
- EUDAMED SRN
- US-MF-000021019
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (4)
- EUDAMED 7cef22b0-38c1-4aed-a9ec-d6a2d5716c3a 61 fields · synced Jul 17, 2026
- EUDAMED 1d4f807a-7e4d-49ef-9deb-e9231391d689 61 fields · synced May 16, 2026
- FDA UDI b38b7135-eb83-4e09-9ad0-30c8d3f4628d 36 fields · synced May 26, 2026
- FDA 510(k) K202544 1 fields · synced May 18, 2026