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Sterilization Pouch / Reel
EUDAMEDClass I (EU MDR)
Ref SP100Model SP100/SP200/SP300/SP400/SP500/ SP600/SP700/SP800/SP900/SP010/ SR050/SR075/SR100/SR150/SR200/ SR250/SR300/SR350/SR400
Identity
- Device Name
- Sterilization Pouch / Reel EUDAMED
- Model / Reference
- SP100/SP200/SP300/SP400/SP500/ SP600/SP700/SP800/SP900/SP010/ SR050/SR075/SR100/SR150/SR200/ SR250/SR300/SR350/SR400 EUDAMEDSP100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974960067004 EUDAMED
- Basic UDI-DI
- 697496006SP100MR EUDAMED
- EMDN Code
- S01020101 FLAT STERILISATION REELS, PAPER/PLASTIC FILM EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Sterilization Pouch / Reel by Xiantao S&J Protective Products Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697496006SP100MR | Class I | Active |
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Manufacturer
- Manufacturer
- Xiantao S&J Protective Products Co., Ltd
- EUDAMED SRN
- CN-MF-000009006
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED f9d91416-029e-4bd9-b8ea-54cc024425b6 61 fields · synced Jul 17, 2026