Disposable Medical Device Self-seal Sterilization Pouch

by Weihai Xingtai Packaging Products Co., Ltd. 28 variants

Ref 250mm×380mm

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number697715353ZFD01NZ Basic UDI-DI 06977153532143UDI-DI	Date18 Jul 2025Registered	StatusActive
United States	GUDID listing GUDID	Number06977153532143 UDI-DI	Date16 Dec 2024Listed	StatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name: Disposable Medical Device Self-seal Sterilization Pouch EUDAMED
Simelo GUDID
Generic Name: Chemical/physical sterilization process indicator
Model / Reference: 250mm×380mm EUDAMED
250mm*380mm GUDID

Primary DI / UDI-DI: 06977153532143
Basic UDI-DI: 697715353ZFD01NZ
510(k) Number: K193561
FDA Product Code: FRG
EMDN Code: S010199 Sterilisation pouches - other
GMDN Term: Chemical/physical sterilization process indicator

Device Class: Class I EUDAMED
Class II GUDID
Regulation Number: 880.6850
EU market of registration: Germany
GUDID distribution status: In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

Field	EUDAMED	GUDID
Model / Reference	EUDAMED 250mm×380mm	GUDID 250mm*380mm
Device Class	EUDAMED Class I	GUDID Class II

Manufacturer details

EUDAMED SRN: CN-MF-000048440
Authorised representative: MedPath GmbH DE-AR-000000087

Other devices from Weihai Xingtai Packaging Products Co., Ltd.

Disposable Medical Device Sterilization Reel Pouch

Class I
Disposable Medical Device Self-seal Sterilization Pouch

Class I
Disposable Medical Device Self-seal Sterilization Pouch

Class I
Disposable Medical Device Self-seal Sterilization Pouch

Class I
Disposable Medical Device Self-seal Sterilization Pouch

Class I
Disposable Medical Device Self-seal Sterilization Pouch

Class I

See all devices from Weihai Xingtai Packaging Products Co., Ltd. →

Properties

Single Use
Lot / Batch Number
Expiration Date
Manufacturing Date

Other properties (20)

Sterile: No
Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Measuring Function: No
Incorporates Medicinal Product: No
Prescription Use: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No