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S.t.i.c.s™ Simple Tracking Identification Color System & Id Tape
EUDAMEDFDA UDIClass I (EU MDR)
Ref T-850-7-04
Identity
- Trade Name
- Batrik Sheet Tape\8.5x11\Y-Red FDA UDI
- Generic Name
- Surgical instrument track identification tape FDA UDI
- Device Name
- S.T.I.C.S™ SIMPLE TRACKING IDENTIFICATION COLOR SYSTEM & ID TAPE EUDAMEDIdentification Sheet Tape, Speciality, Yellow/Red FDA UDI
- Model / Reference
- T-850-7-04 EUDAMEDFDA UDI
- Description
- Identification Sheet Tape, Speciality, Yellow/Red FDA UDI
Identifiers
- Catalog Number
- T-850-7-04 FDA UDI
- Primary DI / UDI-DI
- 00690521003668 EUDAMEDFDA UDI
- Basic UDI-DI
- 6905210IDTAPE1000EE EUDAMED
- FDA Product Code
- MDM FDA UDI
- EMDN Code
- H900299 TAPES, MEDICAL/SURGICAL - OTHER EUDAMED
- GMDN Term
- Surgical instrument track identification tape FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
S.t.i.c.s™ Simple Tracking Identification Color System & Id Tape by Batrik Medical Manufacturing Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6905210IDTAPE1000EE | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Batrik Medical Manufacturing Inc.
- EUDAMED SRN
- CA-MF-000007738
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 8ff8a3c2-225d-49ad-8123-1c02c2d95d66 61 fields · synced Jun 19, 2026
- FDA UDI 839c817e-4e23-4c1d-a8b8-03098f999b34 36 fields · synced May 25, 2026