Identity
- Trade Name
- EndoINK(TM) Endoscopic Marker FDA UDI
- Generic Name
- Injectable charcoal tattoo marker FDA UDI
- Device Name
- Product is black suspension, the content is 5ml. Initial packaging is the syringe. FDA UDI
- Model / Reference
- ENK-05-05 FDA UDI
- Description
- Product is black suspension, the content is 5ml. Initial packaging is the syringe. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06932503562713 FDA UDI
- FDA Product Code
- NBG FDA UDI
- GMDN Term
- Injectable charcoal tattoo marker FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 5 Milliliter FDA UDI
Category: Injectable charcoal tattoo marker
EndoINK(TM) Endoscopic Marker by Micro-Tech (Nanjing) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Injectable charcoal tattoo marker.
- EndoINK(TM) Endoscopic Marker — Micro-Tech (Nanjing) Co., Ltd. · Class II
- BlueBoost(TM) Submucosal Injectable Solution — Micro-Tech (Nanjing) Co., Ltd. · Class II
- EndoINK(TM) Endoscopic Marker — Micro-Tech (Nanjing) Co., Ltd. · Class II
- BlueBoost(TM) Submucosal Injectable Solution — Micro-Tech (Nanjing) Co., Ltd. · Class II
- EndoINK(TM) Endoscopic Marker — Micro-Tech (Nanjing) Co., Ltd. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Micro-Tech (Nanjing) Co., Ltd.
Sources (1)
- FDA UDI 50a94baa-dcd1-428a-a5cf-7b0adffe4109 35 fields · synced May 30, 2026